RESUMO
OBJECTIVE: The study aimed to review the results of endovascular aneurysm repair (EVAR) using a novel sac-anchoring endoprosthesis in patients with favourable and adverse anatomy. DESIGN: This is a prospective, multicentre, clinical trial. MATERIALS: The Nellix endoprosthesis consists of dual, balloon-expandable endoframes, surrounded by polymer-filled endobags, which obliterate the aneurysm sac and maintain endograft position. METHODS: The study reviewed worldwide clinical experience and Core Lab evaluation of computed tomography (CT) scans. RESULTS: From 2008 to 2010, 34 patients (age 71 ± 8 years, abdominal aortic aneurysm (AAA) diameter 5.8 ± 0.8 cm) were treated at four clinical sites. Seventeen patients (50%) met the inclusion criteria for Food and Drug Administration (FDA)-approved endografts (favourable anatomy); 17 (50%) had one or more adverse anatomic feature: neck length <10 mm (24%), neck angle >60° (9%) and iliac diameter >23 mm (38%). Device deployment was successful in all patients; iliac aneurysm treatment preserved hypogastric patency. Perioperative mortality was 1/34 (2.9%); one patient died at 10 months of congestive heart failure (CHF); one patient had a secondary procedure at 15 months. During 15 ± 6 months follow-up, there were no differences in outcome between favourable and adverse anatomy patients. Follow-up CT extending up to 2 years revealed no change in aneurysm size or endograft position and no new endoleaks. CONCLUSIONS: Favourable and adverse anatomy patients can be successfully treated using the Nellix sac-anchoring endoprosthesis. Early results are promising but longer-term studies are needed.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Colômbia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Letônia , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Seleção de Pacientes , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Reoperação , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento , VenezuelaRESUMO
PURPOSE: To report the patient history and analysis of an explanted modular bifurcated endograft that was implanted to exclude an abdominal aortic aneurysm (AAA). CASE REPORT: An 80-year-old man with a 6-cm AAA underwent uneventful endovascular implantation of a bifurcated AneuRx stent-graft. His postprocedural clinical course was uneventful, although persistent contrast enhancement of the aneurysm remained via the inferior mesenteric artery (IMA). By 6 months, an endoleak connecting to the lumbar and mesenteric arteries became apparent. Over the ensuing 12 months, the endoleak and aneurysm enlarged; branch artery embolization was attempted in 4 percutaneous procedures. Despite successful IMA occlusion, the aneurysm continued to increase in diameter and volume, necessitating conversion to a conventional bypass at 20 months. Analysis of the explanted specimen revealed an intact endograft with fibrous incorporation of the stent framework at the proximal and distal fixation sites only; no incorporation of the endograft was noted within the aneurysm. The feeding channel for the endoleak was not identified. CONCLUSIONS: Serial imaging is a vital component of endograft surveillance, and persistent type II endoleaks that cannot be completely embolized endanger the longevity of the aneurysm exclusion. Explant analysis can play an important role in understanding the mechanisms of endograft failure.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Transplantes , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Contraindicações , Análise de Falha de Equipamento , Humanos , Masculino , Artéria Mesentérica Inferior/diagnóstico por imagem , Artéria Mesentérica Inferior/transplante , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/etiologia , Implantação de Prótese , Stents , Tomografia Computadorizada por Raios X , Falha de Tratamento , Procedimentos Cirúrgicos VascularesRESUMO
OBJECTIVE: The objective of this study was to analyze a single-center experience in which descending thoracic aortic aneurysms (TAAs) were treated with a new self-expanding endovascular prosthesis (Medtronic AVE). METHODS: Twenty-six patients (13 men, 13 women) with American Society of Anesthesiology grades II to IV and ages ranging from 53 to 92 years (average, 74 years) consented as part of a Phase I Food and Drug Administration-approved trial. Treated lesions included TAAs that were 5 to 10 cm in diameter, 12 diffuse dilations or fusiform aneurysms, and four saccular aneurysms. There were also nine chronic dissections (2 aneurysmal dilations and 7 symptomatic acute recurrent dissections). Three patients (2 with diffuse/fusiform and 1 with dissection) presented with hemothorax, contrast extravasation, or both. RESULTS: Twenty-five of the 26 patients who consented (96% technical success) were treated successfully with no surgical conversions. Eighteen patients have been followed up from 1 to 22 months (average, 9 months). One patient is lost to follow-up, and six patients have died (24%). One procedure-related death (4%) occurred within the 30-day postoperative period and was caused by diffuse embolization. There were no device-related deaths. Five additional patients (20%) have died during the study of comorbid conditions. Complications included one massive myocardial infarction 24 hours after the procedure requiring balloon counterpulsation and long-term dialysis, one cardiac tamponade resulting from central line placement before the procedure, one progression of aneurysm dilation proximal to the device at 1 year, and one bilateral lower extremity paralysis occurring 12 hours after successful deployment. Seven patients (5 women) had femoral artery reconstructions or iliac artery grafts to repair injuries during deployment catheter passage. Other significant parameters included average procedure time (2 hours 40 minutes; range, 1 hour 30 minutes to 5 hours 30 minutes), 450 cc average blood loss (n = 25; 100-3000 cc) being replaced by means of autotransfusion with only two patients receiving banked blood products, and an average 2 days to resumption of normal diet, 1 day in the intensive care unit, and 5 days' hospitalization postprocedure in uncomplicated cases (n = 22). One patient had an endoleak immediately after the procedure that sealed without treatment. Follow-up of all patients ranging from 1 to 22 months (average, 9 months; n = 18) demonstrates continued exclusion of the aneurysm with no endoleaks and either stable or decreasing aneurysm volume, except in one patient with volume increase and no obvious etiology who continues to be investigated. CONCLUSIONS: The study suggests that endovascular prosthesis exclusion of TAAs with an AneuRx self-expanding tubular device may be effective in many patients who are at significant risk for open surgical repair and substantiates further clinical investigation to confirm these findings.
Assuntos
Aneurisma da Aorta Torácica/cirurgia , Dissecção Aórtica/cirurgia , Stents , Idoso , Idoso de 80 Anos ou mais , Dissecção Aórtica/diagnóstico por imagem , Aneurisma da Aorta Torácica/diagnóstico por imagem , Cateterismo/efeitos adversos , Doença Crônica , Progressão da Doença , Feminino , Seguimentos , Humanos , Processamento de Imagem Assistida por Computador , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Stents/efeitos adversos , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
PURPOSE: To describe an unusual presentation of impending aortic endograft rupture and successful endovascular rescue. CASE REPORT: A 77-year-old man with an enlarging aortic aneurysm was treated with a Talent bifurcated endoprosthesis; a moderate endoleak that appeared to be related to either proximal or distal fixation sites was noted in the body of the aneurysm. The patient was observed for 1 month, and repeat imaging demonstrated persistent endoleak without major increase in the aneurysm diameter. Another examination was scheduled for 3 months hence, but, 2 months later, the patient presented with abdominal pain and a hemoperitoneum. A proximal extension cuff resolved the leak and led to resolution of the hemoperitoneum. CONCLUSIONS: A leaking aneurysm can be repaired using endovascular techniques in patients with an existing endograft. The need for frequent imaging surveillance of patients with endoleak is underscored.
Assuntos
Dor Abdominal/etiologia , Hemoperitônio/etiologia , Idoso , Angioplastia , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/cirurgia , Humanos , Masculino , Procedimentos Cirúrgicos VascularesRESUMO
OBJECTIVES: Assessment of the long-term function of endografts to exclude abdominal aortic aneurysm (AAA) includes determination of aneurysm dimensions and morphologic changes that occur after implantation. This study reports the dimensional analysis of patients treated with AneuRx bifurcated endoprostheses with postintervention, 1-year (n = 51), 2-year (n = 28), and 3-year (n = 10) postimplantation contrast computed tomography data. METHODS: Maximal diameter (D) and cross-sectional area (CSA) of the AAA were measured from axial computed tomography images. Total volume, AAA thrombus volume (AAA volume minus the volume of the device and luminal blood flow), diameter of the aorta at the level of the renal arteries and within the device, distance from the renal arteries to the device, length of the device limbs, and the angle of the proximal neck were also determined at the same follow-up intervals after deployment with computed tomography angiograms reconstructed in an interactive environment. RESULTS: Fifty-one of 98 consecutively treated patients with the AneuRx bifurcated prosthesis (29 "stiff" and 22 "flexible" body devices) had complete data from the postprocedure and follow-up computed tomography studies available for analysis. Max D, CSA, total volume of the AAA, and AAA thrombus volume decreased sequentially from year to year compared with the postimplantation values. D and CSA decreased or were unchanged in all except four patients, two who had unrestricted enlargement of the aneurysm with eventual rupture and one who had surgical conversion for continued expansion despite four diagnostic angiograms and attempted embolizations. Total volume of the AAA increased in 11 of 51 patients at 1 year, eight of whom had endoleaks at some interval during the follow-up. Thrombus volume increased more than 5% in four of these patients, including the two with eventual rupture and the one conversion. Patients with endoleaks who had spontaneous thrombosis or were successfully treated either remained at the same volume or had decreased volume on subsequent examinations. D at the renal arteries increased an average of 0.9 mm during the first year, with a concomitant increase of 2.8 mm within the proximal end of the device related to the self-expanding nature of the Nitinol suprastructure. Subsequent enlargement of the proximal neck continued at a slow rate in some cases but never exceeded the diameter of the endoluminal device. The distance from the renal arteries to the device increased by an average of 3 mm over the first year, with the greatest increases occurring in patients with a "stiff" body device and those with rapid regression (>10% total volume) in 1 year. As regression of the AAA occurred, the angle of the proximal neck varied from -5 degrees to +25 degrees from the original alignment. Limb length varied from -8 mm to +10 mm, with no consistent pattern for the change, that is, ipsilateral or contralateral limb. CONCLUSION: Significant variation in the quantitation of aneurysm size occurs depending on the technique of computed tomography assessment used. In most patients diameter assessment is adequate, although volumetric analysis appears to be very helpful in certain patients who do not show aneurysm regression, or in whom the diameter increases or where endoleaks persist. Three-dimensional reconstruction and volumetric analysis are also useful to assess the mechanism by which the endovascular device accommodates to morphology changes and to determine criteria for reintervention.
Assuntos
Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Cuidados Pós-Operatórios/métodos , Tomografia Computadorizada por Raios X/métodos , Angiografia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Protocolos Clínicos , Seguimentos , Humanos , Seleção de Pacientes , Desenho de Prótese , Falha de Prótese , ReoperaçãoRESUMO
The ability of the Eagle criteria (age >70 years, angina, diabetes, Q wave on EKG, history of congestive heart failure) to predict adverse cardiac events following major vascular surgery has previously been demonstrated. However, the utility of these criteria for lower-extremity amputation is not well established. To determine the value of the Eagle criteria for predicting cardiac morbidity and operative mortality following major lower-extremity amputation, we reviewed 214 consecutive procedures performed at two institutions over a 3-year period. Mean age was 62.7 years and 85% of the patients were male. Diabetes was the most frequent Eagle criterion (74%). The mean number of Eagle criteria was 1.6. Fifty-six percent of the amputations were below the knee, 24% were above the knee, and 20% were guillotine. On multivariate regression analysis, the presence of two or more Eagle criteria (16% vs. 4%, p = 0.04) and decompensated heart failure (39% vs. 7%, p = 0.003) were predictive of adverse cardiac events. The only predictor of postoperative mortality was the presence of two or more Eagle criteria (15% vs. 4%, p = 0.004). Our evaluation of the results of this study led us to conclude that patients requiring major lower-extremity amputation for major vascular disease who have multiple Eagle criteria or decompensated congestive heart failure are at high risk for adverse cardiac events and postoperative death. These findings should be used to guide perioperative cardiac evaluation and therapy.
Assuntos
Amputação Cirúrgica/mortalidade , Cardiopatias/epidemiologia , Idoso , Amputação Cirúrgica/efeitos adversos , Estudos de Casos e Controles , Feminino , Cardiopatias/mortalidade , Mortalidade Hospitalar , Humanos , Perna (Membro) , Masculino , Pessoa de Meia-Idade , Morbidade , Valor Preditivo dos Testes , Análise de Regressão , Fatores de RiscoRESUMO
Extracavitary bypass through the iliac wing allows placement of the grafts into the posterior thigh and is another alternative route when an obturator bypass is not possible, or an axillary-popliteal bypass is to be avoided. The transiliac wing bypass is relatively simple and easy to perform. The bypass route is short and direct, has excellent inflow, and is accompanied by minimal neurological or bleeding risks. An illustrative case is presented with a complete description of the operative technique. Review of the literature is also included.
Assuntos
Implante de Prótese Vascular/métodos , Artéria Ilíaca/cirurgia , Artéria Poplítea/cirurgia , Ferimentos por Arma de Fogo/cirurgia , Adulto , Humanos , Ílio , Masculino , Polietilenotereftalatos , Coxa da Perna/lesõesRESUMO
Intravascular ultrasound (IVUS) has undergone rapid evolution with the recent expansion of endovascular techniques and devices. This device can aid the surgeon, cardiologist, and interventional radiologist by increasing the accuracy of imaging and by adding important information to peripheral vascular and coronary interventions. Modern intravascular ultrasound provides a detailed view of the lumen, wall, and surrounding structures of blood vessels. Compared with other modalities, the diagnostic advantages of IVUS for examining arterial wall architecture and lesion morphology are evident. IVUS can determine lesion shape, length, and configuration, as well as identifying and examining the origins of branches and tributaries. Using this information, IVUS can guide the choice of appropriate angioplasty techniques, aid in the placement of endovascular devices, and assess and follow the efficacy of such interventions. IVUS helps reduce the use of radiation and contrast agents. Even though intravascular ultrasound requires additional equipment, personnel, and interpretative skills, it can be invaluable as a sensitive real-time imaging tool for complex endovascular interventions, therapeutic challenges, and diagnostic dilemmas.
Assuntos
Ultrassonografia de Intervenção/instrumentação , Procedimentos Cirúrgicos Vasculares/métodos , Angioplastia com Balão/métodos , Prótese Vascular , Cateterismo , Desenho de Equipamento , Humanos , StentsRESUMO
OBJECTIVE: The authors analyzed a single group's experience treating abdominal aortic aneurysms (AAAs) with a new self-expanding, modular, bifurcated device. SUMMARY BACKGROUND DATA: Successful exclusion of AAAs by prototype devices has led to several controlled clinical trials evaluating prostheses designed and manufactured specifically for this application. METHODS: Sixteen patients (15 males, 1 female) of American Society of Anesthesiologists grade 2 through 4 and average age of 72 years had AAAs (average 57-mm diameter) treated as part of a phase I Food and Drug Administration-approved trial. RESULTS: All patients were treated successfully with no surgical conversions. No endoleaks or aneurysm enlargement was noted either predischarge by contrast computed tomography or on follow-up at 1 month by duplex ultrasound examination. At 6 months, 12 of 13 patients who were observed for this interval had no endoleaks, whereas one patient (patient 3) showed a small area of extravasation that appeared to arise from the device in an area that was traumatized at the time of deployment. One procedure-related mortality (6%) occurred in a patient who died of septic complications secondary to a gangrenous gallbladder diagnosed 1 day after the procedure. There were no device-related mortalities. Complications included two iliac artery dissections, two groin wound infections, and two transient elevations of serum creatinine. Other significant variables including median procedure length (5 hours), intensive care unit stay (1 day), hospitalization postprocedure (4.5 days), and blood loss (1100 mL) all decreased as the study progressed. Blood replacement in all but three patients was accomplished by autotransfusion or banked-autologous blood replacement. At 6-month follow-up in 13 patients, the maximum diameter of the aneurysm decreased by an average of 5.6 mm (range, 0-15 mm), and the maximal cross-sectional area decreased an average of 20.3% (range, 0-72%). CONCLUSIONS: This study suggests that endovascular prosthesis exclusion of AAAs using a self-expanding modular device may be effective in many patients who are otherwise surgical candidates for repair if further clinical studies confirm these observations.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Idoso , Idoso de 80 Anos ou mais , Angiografia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Meios de Contraste , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Tempo de Internação , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Indução de Remissão , Taxa de Sobrevida , Tomografia Computadorizada por Raios XRESUMO
We describe the regression of a 6.5 cm diameter abdominal aortic aneurysm in a 71-year-old patient within 1 year of aortic endograft placement. The aneurysm decreased in size to 4 cm at 3 months and was 3.3 cm at 8 months on duplex examination. By 1 year a spiral computed tomographic study confirmed complete regression of the aneurysm, with mild shortening and angulation of the unsupported body of the aortoiliac endoluminal prosthesis. The case demonstrates a potential of endograft treatment of aortic aneurysms and decribes the changes in prosthesis configuration and position that occurred after implantation.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Prótese Vascular , Stents , Idoso , Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Humanos , Artéria Ilíaca/diagnóstico por imagem , Masculino , Radiografia , Procedimentos Cirúrgicos Vasculares/métodosRESUMO
This study evaluated deployment mechanics and long-term healing of an endoluminally placed stent/graft in normal canine aortas. The endoluminal graft (ELG) consisted of a 8.5 cm segment of expanded polytetrafluoroethylene (ePTFE) graft material (Impra, Inc., Tempe, AZ) encapsulating a series of six Palmaz P-128 stents (Johnson & Johnson Interventional Incorporated, New Brunswick, NJ) along the length of the graft. The prostheses were deployed via the femoral artery using a 14Fr delivery system that contained a balloon catheter to expand the ELG in the infrarenal aorta. Twenty-one prostheses were deployed and evaluated at 1 week (n = 3), 1 month (n = 3), 3 months (n = 3), 6 months (n = 9), and 1 year (n = 3). Dimensions of the infrarenal aorta were determined with intravascular ultrasound (IVUS) and angiography prior to deployment of devices. Real-time fluoroscopy and IVUS were used to monitor device deployment with both imaging modalities repeated following implantation. Gross inspection and microscopic evaluation was performed on the explanted specimens following in vivo evaluation by CT scan, IVUS, and angiography prior to retrieval of the specimens. The prostheses were easily deployed from the femoral access site. Oversizing of the deployment balloon compared to the aortic diameter was necessary to accommodate the 10% device recoil observed following balloon deflation, however, all devices were seated against the aortic wall as evidenced by IVUS. At explant, all devices ware widely patent with limited luminal thrombosis observed in four specimens (19%). Devices were well-incorporated by cellular ingrowth into the ePTFE with the formation of neointima. No device migration or postdeployment recoil was observed. ePTFE graft material between stents protruded slightly into the vessel lumen accounting for a 10% luminal reduction. Fully supported ELG's consisting of balloon expandable stents encapsulated in ePTFE are easily deployed using a low-profile delivery system. Specimens demonstrated uniform long-term patency and healing up to 1 year in a canine aortic model. Those preliminary findings support further study of this fully supported prosthesis in the treatment of arterial disease.
Assuntos
Aorta Abdominal/cirurgia , Prótese Vascular , Politetrafluoretileno , Stents , Angioplastia com Balão , Animais , Aorta Abdominal/diagnóstico por imagem , Aorta Abdominal/patologia , Materiais Biocompatíveis , Cães , Desenho de Equipamento , Oclusão de Enxerto Vascular/diagnóstico , Tomografia Computadorizada por Raios X , Ultrassonografia de Intervenção , Grau de Desobstrução Vascular , CicatrizaçãoRESUMO
Eighty-nine male veterans presenting to a vascular surgery clinic with symptomatic lower extremity atherosclerosis were prospectively screened by duplex scan for asymptomatic carotid artery stenosis (CAS). Their chief complaint was: claudication (90%), rest pain (6%), and ischemic ulcer or gangrene (4%). The mean ankle-brachial index (ABI) was 0.77. Twenty-five CAS > 50% were detected in 18 (20%) patients. Twelve CAS > 75% were detected in 11 (12%) patients. There was no difference between patients with and without CAS > 50% with regards to mean ABI, history of angina, diabetes, hypertension, prior coronary artery bypass, or history of smoking. Carotid bruit was associated with ipsilateral CAS > 50% [p < 0.0001, sensitivity (52%), specificity (88%), positive predictive value (41%), negative predictive value (92%)]. As a result of the screening, eight elective carotid endarterectomies have been performed to date in six (7%) patients with one transient twelfth cranial nerve paresis as the only postoperative complication. We conclude that: (1) male patients presenting with symptomatic lower extremity atherosclerosis have a 20% prevalence of asymptomatic CAS > 50%, (2) there is no correlation between the degree of lower extremity ischemia and CAS > 50%, (3) carotid bruit is significantly associated with CAS > 50%, but has a low sensitivity, and (4) routine CAS screening should be considered for all male patients with symptomatic lower extremity atherosclerosis regardless of whether a bruit is present.
Assuntos
Arteriosclerose/epidemiologia , Estenose das Carótidas/epidemiologia , Perna (Membro)/irrigação sanguínea , Doenças Vasculares Periféricas/epidemiologia , Idoso , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/prevenção & controle , Estudos de Casos e Controles , Humanos , Masculino , Programas de Rastreamento , Valor Preditivo dos Testes , Prevalência , Estudos Prospectivos , Fatores de Risco , Sensibilidade e Especificidade , Ultrassonografia Doppler DuplaRESUMO
PURPOSE: To describe a case of endoluminal graft exclusion of a proximal para-anastomotic pseudoaneurysm that occurred 17 years following aortobifemoral bypass for occlusive disease. METHODS AND RESULTS: The lesion was found on abdominal ultrasound examination as part of a work-up for acute abdominal pain and upper gastrointestinal bleeding in a 67-year-old male. A 5-cm saccular pseudoaneurysm was confirmed by preintervention aortography and spiral computed tomography (CT) scanning. Because of the patient's acute symptoms and high-risk medical condition (cardiomyopathy), he was deemed a candidate for endoluminal bypass. At the time of intervention, intravascular ultrasound (IVUS) interrogation identified a 3.5-cm-long separation of the existing aortic graft from the proximal aortic stump with a large pseudoaneurysm. The lesion was isolated and repaired by placement of an aortic-to-right iliac endoluminal bypass, ligation of the left limb of the aortofemoral graft, and femorofemoral bypass to restore blood flow to the lower extremities. Spiral CT scans at 48 hours and 3 months following the procedure confirmed complete isolation of the lesion. CONCLUSIONS: This case illustrates the feasibility of endografting for repair of aortic para-anastomotic pseudoaneurysms, and it also highlights the potential role of IVUS imaging in endoluminal graft deployment.
Assuntos
Anastomose Cirúrgica/métodos , Falso Aneurisma/cirurgia , Angioplastia/métodos , Doenças Vasculares Periféricas/cirurgia , Complicações Pós-Operatórias/cirurgia , Idoso , Falso Aneurisma/complicações , Falso Aneurisma/diagnóstico , Angiografia , Aorta , Artéria Femoral , Seguimentos , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/cirurgia , Humanos , Artéria Ilíaca , Perna (Membro)/irrigação sanguínea , Ligadura/métodos , Masculino , Doenças Vasculares Periféricas/complicações , Doenças Vasculares Periféricas/diagnóstico , Reoperação , Tomografia Computadorizada por Raios X , Ultrassonografia de IntervençãoAssuntos
Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Anticoagulantes/efeitos adversos , Anticoagulantes/química , Anticoagulantes/farmacologia , Heparina/efeitos adversos , Heparina de Baixo Peso Molecular/química , Heparina de Baixo Peso Molecular/farmacologia , Humanos , Agregação Plaquetária , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombocitopenia/induzido quimicamente , Trombocitopenia/terapia , Trombose/prevenção & controle , Procedimentos Cirúrgicos VascularesRESUMO
PURPOSE: The study evaluated the deployment and healing of a novel self-expanding modular bifurcation endovascular prosthesis in a canine abdominal aortic aneurysm model. The endoluminal prosthesis consists of self-expanding nitinol stents lined by a synthetic prosthesis. One component of the device is a bifurcated body with a 12- to 14-mm diameter aortic segment and an integral 7- to 8-mm diameter iliac limb. The bifurcated body also has a stent-reinforced opening (pant-leg) for subsequent insertion of a contralateral 7- to 8-mm diameter iliac limb component. METHODS: Seventeen bifurcated prosthesis were placed; 7 were inserted through the left common carotid artery and 10 from the femoral arteries. With either route of access the 16F or 17F aortoiliac limb and the 13F iliac limb delivery catheters enabled easy passage and secure positioning of the bifurcated prostheses. Predeployment and postdeployment inspection of the dimensions and continuity of the aortoiliac prosthetic components were evaluated by cinefluoroscopy and intravascular ultrasonography (IVUS). RESULTS: After deployment was done, interval patency was assessed with angiography, IVUS, and contrast-enhanced computed tomography with the prostheses removed for analysis at 1 week (n = 4), 1 month (n = 3), 3 months (n = 4), and 6 months (n = 6). Five of the first seven implanted prostheses had occlusion of segments of the device. In two dogs the bifurcated body and both legs were occluded. In the other three the nonoccluded leg and bifurcation body were fully patent. In the first seven animals IVUS at implantation showed compression of an iliac leg by the orifice of the contralateral iliac component. After concentric fixation of the flow divider was performed, only one additional iliac limb occlusion occurred in the next 10 animals. Cinefluoroscopy, computed tomography, IVUS imaging, and histologic analysis of retrieved specimens demonstrated healing of the aortoiliac prostheses without evidence of perigraft leaks. CONCLUSIONS: This feasibility study demonstrates the ability to deploy and maintain acceptable patency of a self-expanding endoluminal, modular bifurcation prosthesis in a canine aortic model. Clinical evaluation of the device is planned for the near future.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Prótese Vascular , Ligas , Animais , Prótese Vascular/métodos , Cães , Estudos de Viabilidade , Seguimentos , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/epidemiologia , Desenho de Prótese , Stents , Fatores de Tempo , Grau de Desobstrução VascularRESUMO
PURPOSE: This report reviews our preliminary experience of prospective treatment of arterial lesions with endoluminal grafts in a Food and Drug Administration (FDA)-approved, investigator-sponsored Investigation Device Exemptions study. The utility and accuracy of various imaging methods, including angiography, cinefluoroscopy, computed tomography (CT), intravascular ultrasonography (IVUS), and duplex scanning, in performing the procedures was also assessed. METHODS: Thirty-one patients were evaluated; 17 patients were treated, including 11 with abdominal aortic aneurysms, one with an aortic occlusive lesion, two with iliac artery aneurysms, and three with traumatic arteriovenous fistulas. Twelve of the 14 patients who had aorta and iliac artery lesions were high-risk. The mean follow-up of patients treated was 9 months (range, 6 to 15 months). RESULTS: Aortoaortic endoluminal interposition procedures were not successful for treating abdominal aortic aneurysms early in the study (n = 3). Aortoiliac endoluminal bypass, contralateral iliac artery occlusion, and femorofemoral bypass procedures were successful in seven of eight subsequent cases (88%), with no incidence of endoleaks at either the proximal or distal fixation sites using the deployment methods described in this report. The 30-day operative mortality rate on follow-up evaluations for patients who underwent aortoiliac procedures was 14% (two of 14). Other major complications included transient renal failure in three patients that required short-term (two to eight times) dialysis, one arterial perforation and one dissection, and one prolonged intubation. No myocardial infarctions or strokes occurred. After major complications or identification of limitations in the study, the protocol was modified with the approval of the FDA to help avoid the recurrence of the same problems. There were no deaths or complications in the trauma cases. CONCLUSIONS: Contrast-enhanced CT (axial images and spiral reconstructions) was the most accurate method to determine candidacy for aortoiliac procedures and to choose the site for deployment of the devices. Angiographic scans were misleading in several patients regarding the critical determinants of patient candidacy and device deployment, particularly regarding the presence of a distal aortic neck. Cinefluoroscopy was used in all patient and was particularly useful for determining the continuity of vascular structures and the anatomy of branch arteries and for enabling precise positioning of stent devices. Determination of fixation sites and assessing dimensional information by cinefluoroscopy and angiography were limited by inaccuracies produced by image magnification, parallax, and uniplanar views. IVUS was used to determine the morphologic features of vascular structures (i.e., calcium, thrombus), to perform real-time observation of the expansion of devices, and to assure firm fixation of balloon-expanded stents before the procedures were completed. Duplex scanning was very helpful in assessing and identifying precisely the location of arteriovenous fistulas before intervention and provided assessment at follow-up intervals. Three-dimensional reconstruction imaging technologies such as spiral CT were particularly helpful for assessing the morphologic features of vascular anatomy before the intervention and at follow-up intervals, whereas 3-D IVUS provided a similar real-time perspective during the procedure.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Artérias/lesões , Prótese Vascular , Aneurisma Ilíaco/cirurgia , Stents , Idoso , Idoso de 80 Anos ou mais , Falso Aneurisma/diagnóstico , Falso Aneurisma/cirurgia , Angiografia , Aneurisma da Aorta Abdominal/diagnóstico , Doenças da Aorta/diagnóstico , Doenças da Aorta/cirurgia , Arteriopatias Oclusivas/diagnóstico , Arteriopatias Oclusivas/cirurgia , Feminino , Humanos , Aneurisma Ilíaco/diagnóstico , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Prospectivos , Fatores de Risco , Tomografia Computadorizada por Raios X , Ultrassonografia de IntervençãoAssuntos
Falência Renal Crônica/complicações , Doenças Vasculares Periféricas/cirurgia , Procedimentos Cirúrgicos Vasculares/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos como Assunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Vasculares Periféricas/complicações , Prognóstico , Fatores de Risco , Taxa de SobrevidaRESUMO
PURPOSE: To describe the deployment technique, function, and gross healing of an endoluminal vascular prosthesis deployed in a high-risk patient for treatment of a common iliac artery (CIA) aneurysm. METHODS: An 82-year-old, high-risk male with a 4-cm-diameter CIA aneurysm approximately 4.5 to 5 cm long was treated with endoluminal exclusion of the lesion using a 6-cm-long, 14-mm-internal diameter Dacron vascular prosthesis with Palmaz 308 stents sutured to either end of the graft. Intravascular ultrasound (IVUS) imaging facilitated sizing of the endograft and its accurate positioning so as to occlude both the aneurysm and the hypogastric artery, which was a potential source of retrograde flow to the aneurysm. Exclusion of the lesion and occlusion of the hypogastric artery were demonstrated on delayed angiographic images and contrast computed tomography scans obtained at 16 days postprocedure. Unfortunately, the patient died 67 days following implantation from a nonprocedure-related gastrointestinal complication. RESULTS: At autopsy, the aortoiliac segment was excised and examined grossly and histologically; the evaluation confirmed complete isolation of the aneurysm by the fully expanded endoluminal prosthesis. The surface of the vascular graft was covered by a glistening, thin, fibrinous membrane. The graft material was filled with hypocellular compact fibrinous material with no evidence of endothelialization. These observations confirm preliminary sealing and isolation of the iliac artery aneurysm as healing of the endograft progressed. CONCLUSIONS: The data acquired from the analysis of this specimen provide information regarding the utility and early healing of an endograft used for iliac artery aneurysm exclusion. This case also exemplifies the utility of IVUS in endograft deployment.