RESUMEN
PURPOSE: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis. RESULTS: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days. CONCLUSIONS: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions. CLINICAL IMPACT: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure.
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Aneurisma Falso , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Infecciones Relacionadas con Prótesis , Humanos , Aneurisma Falso/cirugía , Aneurisma Falso/diagnóstico por imagen , Aneurisma Falso/microbiología , Aneurisma Falso/etiología , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Infecciones Relacionadas con Prótesis/cirugía , Infecciones Relacionadas con Prótesis/microbiología , Infecciones Relacionadas con Prótesis/diagnóstico , Masculino , Resultado del Tratamiento , Anastomosis Quirúrgica/efectos adversos , Anciano , Stents/efectos adversos , Aneurisma Infectado/cirugía , Aneurisma Infectado/microbiología , Aneurisma Infectado/diagnóstico por imagenRESUMEN
Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The study included 76 NO-CLI patients admitted to our centers because of CLI with DFUs. All patients were treated with the same standard care (control group), but 38 patients were also treated with autologous PBMNC implants. Major amputations, overall mortality, and number of healed patients were evaluated as the primary endpoint. Only 4 out 38 amputations (10.5%) were observed in the PBMNC group, while 15 out of 38 amputations (39.5%) were recorded in the control group (p = 0.0037). The Kaplan-Meier curves and the log-rank test results showed a significantly lower amputation rate in the PBMNCs group vs. the control group (p = 0.000). At two years follow-up, nearly 80% of the PBMNCs group was still alive vs. only 20% of the control group (p = 0.000). In the PBMNC group, 33 patients healed (86.6%) while only one patient healed in the control group (p = 0.000). PBMNCs showed a positive clinical outcome at two years follow-up in patients with DFUs and NO-CLI, significantly reducing the amputation rate and improving survival and wound healing. According to our study results, intramuscular and peri-lesional injection of autologous PBMNCs could prevent amputations in NO-CLI diabetic patients.
RESUMEN
A 89-year-old male presented with severe untreatable pain and ischemic non-healing ulcer in the left forefoot. The pre-procedural angiograms showed multiple stenosis of the superficial femoral and popliteal arteries, occlusion of anterior tibial artery, tibio-peroneal trunk (TTP) and distal posterior tibial artery (PTA), stenosis of the peroneal artery, and the patency of the medial plantar artery (MPA) as a single pedal artery, with very poor perfusion of the lateral aspect of the forefoot. The TTP and PTA were recanalized, and balloon angioplasty of superficial femoral artery and popliteal artery and peroneal artery was carried out. After unsuccessful antegrade attempts, the lateral plantar artery (LPA) was retrogradely recanalized performing the medial-to-lateral plantar loop, navigating from the deep branch of MPA to the plantar arch and reentering back in the common plantar artery through the LPA. Balloon angioplasty of LPA was performed though the retrograde and antegrade route. When the MPA is the single pedal artery, and the antegrade recanalization of the dorsalis pedis artery (DPA) and the LPA is not possible, the medial-to-lateral plantar loop is a feasible technique to recanalize the LPA retrogradely through the plantar arch.
Asunto(s)
Angioplastia de Balón , Arterias Tibiales , Anciano de 80 o más Años , Arteria Femoral , Humanos , Isquemia/diagnóstico por imagen , Isquemia/etiología , Isquemia/cirugía , Masculino , Arteria Poplítea , Arterias Tibiales/diagnóstico por imagen , Arterias Tibiales/cirugía , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
PURPOSE: To investigate the efficacy and safety of a tailored approach to fit access and engagement techniques to the individual arch anatomy in patients with bovine-type aortic arch (BTAA) to overcome the perceived increased risk of technical failure and cerebral embolization during left internal carotid artery (LICA) stenting. METHODS: Thirty-five high surgical risk patients (23 men; mean age 68.6 years, range 62-90) with BTAA and LICA stenosis underwent carotid artery stenting (CAS). Left common carotid artery (LCCA) engagement was achieved by means of different techniques according to the configuration of the BTAA, arch type (I, II, or III), and angle between the innominate artery and the LCCA. The clinical, anatomical, and procedural data were retrieved from a prospectively maintained database and analyzed retrospectively to identify technical modifications required during the procedure compared with planning. RESULTS: The technical success rate was 100%. Transfemoral access was used in 21 (60%) cases. In this group, the soft engagement technique with hockey stick (HS) guiding catheter and buddy wire in the external carotid artery (ECA) was used in 13 (62%) cases, a simple telescopic technique with 6-F armed introducer or 7-F 40° guiding catheter in 5 (24%) cases, and a sequential technique with a MOMA proximal protection system in the remaining 3 (14%) cases. Among the 14 (40%) right brachial access cases, the telescopic technique with 6-F armed introducer was used in 13 cases. The remaining case was the only one in which the planned technique was changed (from the telescopic to sequential technique with ECA wire exchange). There were no intraprocedural or 30-day neurological events. CONCLUSION: An appropriate tailored interventional strategy, planned by means of preprocedural recognition of bovine arch anatomy, is associated with satisfactory safety and good success.
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Angioplastia de Balón/instrumentación , Angioplastia de Balón/métodos , Aorta Torácica/anomalías , Arteria Carótida Interna , Estenosis Carotídea/terapia , Stents , Malformaciones Vasculares/complicaciones , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Aorta Torácica/diagnóstico por imagen , Arteria Carótida Interna/diagnóstico por imagen , Arteria Carótida Interna/patología , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico , Femenino , Humanos , Italia , Angiografía por Resonancia Magnética , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , Malformaciones Vasculares/diagnósticoRESUMEN
BACKGROUND: To compare the results of the endovascular aneurysm repair (EVAR) in patients considered as unfit for surgery in a "high volume" center with the EVAR-2 trial results. METHODS: In our center, between January 2006 and December 2008, 469 endovascular aorta treatments were performed in high-risk patients. All the data were prospectively collected in a database. Among 469 patients, we selected 191 patients considered as unfit for open surgery (group 1) corresponding to the EVAR trial criteria. Variables such as postoperative mortality at 30 days and 1 year, complications rates, as well as early and late redo surgery were evaluated. Long-term pharmacological treatment before surgery was listed. These results were compared with the EVAR trial (group 2). Survival during the follow-up was calculated according to the Kaplan-Meier method. RESULTS: Mortality at 30 days was 1.6% and 9% in groups 1 and 2, respectively (p = 0.002). Global complication rate was 44% and 43% in groups 1 and 2, respectively (p = 0.52). Over the follow-up period, the redo surgery rate was 13% and 26% in groups 1 and 2, respectively (p = 0.0102). In our cohort, the survival rate at 2 years was 84% with a residual number of 102 patients. Before surgery, a long-term antiplatelet treatment was prescribed in 89% and 58% of the patients and statins in 74% and 39% of the patients in groups 1 and 2, respectively (p < 0.0001). CONCLUSION: The EVAR-2 trial conclusions are in opposition to the practice of French vascular surgeons. Endovascular treatment of abdominal aortic aneurysms in high-risk patients is justified. This study confirms the importance of a multidisciplinary treatment for high-risk patients in high-volume centers.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Distribución de Chi-Cuadrado , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Medicina Basada en la Evidencia , Francia , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Estimación de Kaplan-Meier , Selección de Paciente , Inhibidores de Agregación Plaquetaria/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Tasa de Supervivencia , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
PURPOSE: To describe our experience with the use of custom-designed branched or fenestrated endoprostheses incorporating an inverted contralateral limb in the bifurcated component. METHODS: Retrospective analysis was performed of a prospectively maintained database of all patients undergoing endovascular aneurysm repair using modular branched or fenestrated devices at a university teaching hospital between January 2004 and February 2010. Of 102 cases, 7 male patients (mean age 69 years) were treated with modular devices that incorporated an inverted contralateral limb in the bifurcated component. Five patients had thoracoabdominal aortic aneurysm (4 type IV and 1 type II), 1 patient had a pararenal abdominal aortic aneurysm, and another had type I endoleak from a migrated AneuRx stent-graft. The technique was used primarily because of an existing bifurcated prosthesis (n=5), but in 2 patients without prior open surgery, this technique was needed because of anatomical constraints. RESULTS: All devices were implanted as planned. There was no mortality. One patient required temporary hemodialysis prior to discharge; another patient developed permanent paraplegia, likely related to extensive aortic coverage. No device migration, component separation, or type I or III endoleaks were detected during a mean follow-up of 25 months, and no reinterventions have been necessary. CONCLUSION: The use of an inverted limb in the bifurcated component of modular endografts may allow endovascular treatment in scenarios where there is insufficient space to deploy a standard bifurcated component. This design modification allows an adequate sealing zone between the iliac extension limbs and the bifurcated component.
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Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Anciano , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Francia , Humanos , Enfermedades Renales/etiología , Enfermedades Renales/terapia , Masculino , Persona de Mediana Edad , Paraplejía/etiología , Diseño de Prótesis , Diálisis Renal , Reoperación , Estudios Retrospectivos , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
PURPOSE: To describe the novel use of an Amplatzer occluder device to seal a secondary endoleak arising at a scallop in a fenestrated stent-graft. CASE REPORT: A 67-year-old man with comorbidities precluding standard endovascular repair of a pararenal aortic aneurysm was treated with a fenestrated endoprosthesis containing one fenestration for the left renal artery and one scallop for the celiac trunk; the right renal and superior mesenteric arteries were occluded at presentation. Interval imaging at 2 years showed a proximal type I endoleak at the celiac trunk scallop associated with expansion of the aneurysm sac. Attempted repair with an aortic extension cuff and a "chimney" stent was unsuccessful. An Amplatzer Patent Foramen Ovale occluder device was deployed across the endoleak to provide aneurysm sac exclusion, which has been maintained at 6-month follow-up. CONCLUSION: Treatment of a secondary type I endoleak after implantation of a fenestrated endoprosthesis is challenging. The novel use of an Amplatzer occluder in this setting may be applicable to other situations in which an endovascular solution is desirable for complications of complex endovascular aneurysm repair.
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Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Falla de Prótesis , Dispositivo Oclusor Septal , Stents , Anciano , Aneurisma de la Aorta/diagnóstico por imagen , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Humanos , Masculino , Diseño de Prótesis , Reoperación , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
PURPOSE: To evaluate the influence of serum lipid subfraction concentrations on arterial patency after percutaneous transluminal angioplasty (PTA) in patients with infrainguinal peripheral artery occlusive disease (PAOD). METHODS: From January 2007 to June 2008, a prospective study was conducted involving 39 patients (29 men; mean age 68.6+/-10.0 years) with infrainguinal PAOD in 41 limbs who had preprocedural lipid assessment and underwent successful PTA (<30% residual stenosis). Patient demographics, Fontaine clinical stage classification, Texas University Classification of ulcers, coexisting medical conditions, endovascular procedures, and lipid profiles were collected in a database. Follow-up included clinical and duplex ultrasound evaluation at discharge and at 1, 3, 6, and 12 months. To analyze any correlation between various lipid subfractions and the loss of primary patency (Cox proportional hazards modeling), the patients were dichotomized into high and low groups according to these thresholds: LDL-C >100 mg/dL, HDL-C <40 mg/dL, Lp(a) >30 mg/dL, and an Apo(B)/Apo(A) ratio >0.8 mg/dL. RESULTS: Mean follow-up was 7.5 months (range 3-12). After 1, 3, and 6 months, the primary patency rates by Kaplan-Meier analysis were 94.9%, 73.7%, and 64.1%, respectively. Restenosis at 6 months was significantly related to female gender (HR 95.9, 95% CI 6.8 to 1352.5, p = 0.001), HDL-C <40 mg/dL (HR 86.9, 95% CI 6.4 to 1183.1, p = 0.001), LDL-C >100 mg/dL (HR 9.6, 95% CI 1.6 to 57.4, p = 0.013), and Lp(a) >30 mg/dL (HR 6.1, 95% CI 1.4 to 26.3, p = 0.016). CONCLUSION: Our results suggest that Lp(a), LDL-C, and HDL-C are independent risk factors for restenosis after infrainguinal PTA.
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Angioplastia de Balón , Arteriopatías Oclusivas/sangre , Oclusión de Injerto Vascular/etiología , Pierna/irrigación sanguínea , Lipoproteínas/sangre , Enfermedades Vasculares Periféricas/sangre , Anciano , Arteriopatías Oclusivas/terapia , Estudios de Cohortes , Femenino , Oclusión de Injerto Vascular/sangre , Humanos , Masculino , Persona de Mediana Edad , Enfermedades Vasculares Periféricas/terapia , Estudios Retrospectivos , Factores de Riesgo , Stents , Resultado del Tratamiento , Grado de Desobstrucción Vascular/fisiologíaRESUMEN
PURPOSE: To evaluate arterial patency and factors influencing outcomes after successful tibial artery angioplasty in patients with critical limb ischemia (CLI). METHODS: From January 2005 to August 2007, a prospective single-center study was conducted involving 80 CLI patients (56 men; mean age 71.7+/-8.8 years) who underwent successful tibial artery angioplasty (<30% residual stenosis) in 87 limbs. Eighty (92%) limbs showed ischemic ulcers or gangrene at baseline. In two thirds, a more proximal lesion was treated, and a secondary stent was implanted in 14 (16%). Follow-up included clinical examination for wound healing (WH), limb salvage (LS), and duplex-documented target vessel patency or restenosis at discharge and at 1, 3, 6, 9, 12, 18, and then every 6 months. Patency rates, WH, and LS were assessed with the Kaplan-Meier method, and factors influencing these outcomes were analyzed using Cox proportional hazards models. RESULTS: Mean follow-up was 10.9 months (range 2 days - 29 months). At 12 months, the primary and assisted primary patency rates were 37.9% and 71.2%, respectively. Restenosis was significantly correlated with smoking (HR 3.58, 95% CI 1.15 to 11.18; p = 0.02), infected ulcers (HR 2.04, 95% CI 1.02 to 4.09; p = 0.04), and posterior tibial artery angioplasty (HR 3.76, 95% CI 1.59 to 8.87; p = 0.003). Rates of LS and WH at 12 months were 92.7% and 74.9%, respectively. Peroneal angioplasty was significantly correlated with WH (HR 1.83, 95% CI 1.04 to 3.25; p = 0.03), and wound healing increased with classes of age (HR 1.60, 95% CI 1.07 to 2.39; p = 0.02). CONCLUSION: One-year restenosis after optimal tibial artery angioplasty is significant and positively correlated with smoking, infection of trophic lesions, and posterior tibial artery angioplasty. Close ultrasound surveillance provides good limb salvage after optimal infrapopliteal angioplasty in patients with CLI.