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1.
Artículo en Inglés | MEDLINE | ID: mdl-38331163

RESUMEN

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

2.
Medicina (Kaunas) ; 59(10)2023 Oct 17.
Artículo en Inglés | MEDLINE | ID: mdl-37893562

RESUMEN

Background and Objectives: This study aims to identify the minor allele of the single nucleotide polymorphisms (SNPs) DAB2IP rs7025486, IL6R rs2228145, CDKN2BAS rs10757278, LPA rs3798220, LRP1 rs1466535, and SORT1 rs599839 in order to assess the risk of abdominal aortic aneurysm (AAA) formation and define the linkage among these SNPs. Materials and Methods: A case-control study with AAA patients (AAA group) and non-AAA controls (control group) was carried out in a study population. DNA was isolated from whole blood samples; the SNPs were amplified using PCR and sequenced. Results: In the AAA group of 148 patients, 87.2% of the patients were male, 64.2% had a history of smoking, and 18.2% had relatives with AAA. The mean ± SD of age, BMI, and aneurysmal diameter in the AAA group were 74.8 ± 8.3 years, 27.6 ± 4.6 kg/m2, and 56.2 ± 11.8 mm, respectively. In comparison with 50 non-AAA patients, there was a significantly elevated presence of the SNPs DAB2IP rs7025486[A], CDKN2BAS rs10757278[G], and SORT1 rs599839[G] in the AAA group (p-values 0.040, 0.024, 0.035, respectively), while LPA rs3798220[C] was significantly higher in the control group (p = 0.049). A haplotype investigation showed that the SNPs DAB2IP, CDKN2BAS, and IL6R rs2228145[C] were significantly elevated in the AAA group (p = 0.037, 0.037, and 0.046) with minor allele frequencies (MAF) of 25.5%, 10.6%, and 15.4%, respectively. Only DAB2IP and CDKN2BAS showed significantly higher occurrences of a mutation (p = 0.028 and 0.047). Except for LPA, all SNPs were associated with a large aortic diameter in AAA (p < 0.001). Linkage disequilibrium detection showed that LPA to DAB2IP, to IL6R, to CDKN2BAS, and to LRP1 rs1466535[T] had D' values of 70.9%, 80.4%, 100%, and 100%, respectively. IL6R to LRP1 and to SORT1 had values for the coefficient of determination (r2) of 3.9% and 2.2%, respectively. Conclusions: In the investigated study population, the SNPs CDKN2BAS rs10757278, LPA rs3798220, SORT1 rs599839, DAB2IP rs7025486, and IL6R rs2228145 were associated with the development of abdominal aortic aneurysms. Individuals with risk factors for atherosclerosis and/or a family history of AAA should be evaluated using genetic analysis.


Asunto(s)
Aneurisma de la Aorta Abdominal , Predisposición Genética a la Enfermedad , Humanos , Masculino , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Casos y Controles , Polimorfismo de Nucleótido Simple/genética , Aneurisma de la Aorta Abdominal/genética , Factores de Riesgo , Inflamación , Apoptosis , Colesterol , Proteínas Activadoras de ras GTPasa/genética
3.
J Endovasc Ther ; 28(4): 585-592, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-34060354

RESUMEN

OBJECTIVE: To evaluate early and follow-up outcomes following bilateral use of iliac branch devices (IBD) for aortoiliac endografting and assess the impact of center volume. We used data from the pELVIS international multicentric registry. METHODS: For the purpose of this study, only those patients receiving concomitant bilateral IBD implantation were analyzed. To assess the impact that procedural volume of bilateral IBD implantation could have on early and follow-up outcomes, participating institutions were classified as Site(s) A if they had performed >10 and/or >20% concomitant bilateral IBD procedure, otherwise they were classified as Site(s) B. Endpoints of the analysis included early (ie, 30-day) mortality and morbidity, as well as all-cause and aneurysm-related mortality during follow-up. Additional endpoints that were evaluated included IBD-related reinterventions, IBD occlusion or stenosis requiring reintervention (ie, loss of primary patency), and IBD-related type I endoleak. RESULTS: Overall, 96 patients received bilateral IBD implantation (out of 910 procedures collected in the whole pELVIS cohort), of whom 65 were treated at Site A (ie, Group A) and 31 were treated at Site(s) B (ie, Group B). In total, only 1 death occurred within 30 days from bilateral IBD implantation, and 9 patients experienced at least 1 major complication without any significant difference between subjects in Group A versus those in Group B (10.8% vs 6.5%, p=0.714). In the overall cohort, the 2-year freedom from IBD-related type I endoleaks and IBD primary patency were 96% and 92%, respectively; no significant differences were seen in those rates between Group A or Group B (95% vs 100%, p=0.335; 93% vs 88%, p=0.470). Freedom from any IBD-related reinterventions was 83% at 2 years, with similar rates between study groups (85% vs 83%, p=0.904). CONCLUSIONS: Within the pELVIS registry, concomitant bilateral IBD implantation is a safe and feasible technique for management of aortoiliac aneurysms in patients with suitable anatomy. Despite increased technical complexity, effectiveness of the repair is satisfactory with low rates of IBD-related adverse events at mid-term follow-up. Procedural volume does not seem to affect technical or clinical outcomes after bilateral use of IBD, which remains a favorable treatment option in selected patients.

4.
Eur J Vasc Endovasc Surg ; 61(4): 591-602, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33573913

RESUMEN

OBJECTIVE: The aim was to identify predictors of adequate pre-operative sizing and planning for chimney endovascular aortic repair (ChEVAR) in order to reduce the incidence of persistent type Ia endoleaks (IaELs) without influencing chimney graft (CG) patency. METHODS: Consecutive patients who underwent ChEVAR between January 2009 and December 2017 at a single centre were evaluated retrospectively. Included were patients treated with one device combination (Medtronic Endurant mated with Getinge Advanta V12/iCast) and placement of single or double CG. The freedom from IaEL related re-interventions and primary CG patency was estimated by measuring aortic stent graft oversizing (OS), total neck length (TNL), and a composite parameter (L-OS: TNL [mm] + OS [%]). RESULTS: Seventy-three patients who underwent placement of 101 CGs (45 single, 28 double) met the inclusion criteria. The median radiological follow up was 25.5 (interquartile range [IQR] 12-48) months. Freedom from IaEL related re-intervention was achieved in 94.6% with a median OS of 38.5% (IQR 30%-44%, p = .004), TNL 19 mm (16-25 mm, p = .62), and L-OS 59 (51-65, p = .018). Primary CG patency was achieved in 95% of the cases with a median OS of 36% (29%-42%, p = .008), TNL 19 mm (15.5-26 mm, p = .91), and L-OS 57 (50-64, p = .005). By using the receiver operating characteristic curve, an optimal cut off to prevent IaEL related re-interventions was identified by an OS of 30% (p < .001; L-OS 55, p = .006) and to avoid CG stenosis/occlusions by OS 42% (p < .001; L-OS 65, p < .001). In multivariable analysis, aortic endograft OS was the only independent parameter preventive for IaEL related re-intervention (odds ratio, 0.78; 95% confidence interval, 0.61-0.99). CONCLUSION: With the Endurant-Advanta V12/iCast combination, an aortic stent graft OS of at least 30% (range 30%-42%) should be used to avoid type Ia endoleaks and likewise to ensure CG patency.


Asunto(s)
Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Anciano de 80 o más Años , Aorta Abdominal/diagnóstico por imagen , Aorta Abdominal/fisiopatología , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/fisiopatología , Aortografía , Implantación de Prótesis Vascular/efectos adversos , Angiografía por Tomografía Computarizada , Bases de Datos Factuales , Endofuga/etiología , Endofuga/prevención & control , Procedimientos Endovasculares/efectos adversos , Femenino , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/prevención & control , Humanos , Masculino , Diseño de Prótesis , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular
5.
Vascular ; 29(6): 808-816, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33375927

RESUMEN

OBJECTIVES: The results of branched endovascular repair of thoracoabdominal aneurysms are mainly dependent on durability of the graft used. The purpose of this study was to evaluate postoperative aortic main body and bridging stent-graft remodeling, and their impact on bridging stent-graft instability at one year. METHODS: Computed tomoangiographies of 43 patients (43 aortic main body mated with 171 bridging stent-grafts) were analyzed before and after branched endovascular repair as well as after a follow-up of 12 months. Primary endpoint was aortic main body remodeling (migration >5 mm, shortening >5 mm, scoliosis >5° or lordosis >5°). Shortening was defined as a reduced length in the long axis, scoliosis as left-right curvature, and lordosis as antero-posterior curvature. Aortic main body remodeling, aneurysm sac changes, and bridging stent-graft tortuosity were evaluated to study their correlations and the impact on the bridging stent-graft instability. RESULTS: At 12 months, aortic main body remodeling was observed in 72% of the cases, migration in 39.5% (mean 5.21 mm), shortening in 41.9% (mean 5.79 mm), scoliosis in 58.1%, (mean 10.10°), lordosis in 44.2% (mean 5.78°). Migration, shortening, and scoliosis were more frequent in patients with larger aneurysms (p = .005), while scoliosis was significantly more frequent in type II thoracoabdominal aneurysm (p = .019). Aortic main body remodeling was significantly associated to bridging stent-graft remodeling (r: 0.3-0.48). The bridging stent-graft instability rate was 9.3%. Despite a trend toward significance (p = .07), none of the evaluated aortic main body and bridging stent-graft changes were associated with bridging stent-graft instability at 12 months. CONCLUSIONS: Aortic main body remodeling is frequent especially in large and extended thoracoabdominal aneurysm aneurysms. Aortic main body and bridging stent-graft remodeling was significantly correlated. While these geometric changes had no significant impact on bridging stent-graft instability at one year, a close long-term follow-up after branched endovascular repair could predict bridging stent-graft failures.


Asunto(s)
Aorta/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Remodelación Vascular , Anciano , Aorta/diagnóstico por imagen , Aorta/fisiopatología , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/fisiopatología , Implantación de Prótesis Vascular/efectos adversos , Bases de Datos Factuales , Procedimientos Endovasculares/efectos adversos , Femenino , Migración de Cuerpo Extraño/etiología , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Falla de Prótesis , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento
6.
Vascular ; 29(2): 213-219, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32741310

RESUMEN

OBJECTIVES: Endovascular therapy using balloon expandable stents has become the treatment standard for most iliac atherosclerotic lesions. We aimed to assess the safety and performance of the Dynamic stainless-steel balloon-expanding stent system in this location. METHODS: BIODYNAMIC is a retrospective single center study including consecutive patients with iliac lesions treated with the Dynamic stent system. Not included were implantations inside an endograft. The primary endpoint was freedom from major adverse limb events (MALE) at 12 months, defined as index limb amputation or target lesion revascularization (TLR). Secondary endpoints were procedure success, ankle brachial index (ABI) and Rutherford class change, mortality and freedom from TLR after 12 months. RESULTS: Within two years, 182 patients with 234 lesions in the common iliac artery were enrolled. Rutherford class 5 and 6 were present in 11.5% of patients, average stent diameter was 8.0 ± 0.5 mm and stented length 40.0 ± 15.3 mm. The primary endpoint was reached in 96.2% (225/234) of the cases, with six TLR (2.6%) and three target limb amputations (1.3%). Procedure success was obtained in all but three patients (98.4%). In paired analysis, ABI improved by 0.25 ± 0.21 from baseline to 0.90 ± 0.16 post-procedure and Rutherford class improved by -1.75 ± 1.53. There were four non-device-related deaths (2.2%). Freedom from TLR was 97%, 95.3%, 94% and 92.7% at 24, 36, 48 and 60 months, respectively. CONCLUSION: The Dynamic balloon-expandable stent system proved to be safe and effective in a population with common iliac artery lesions.


Asunto(s)
Angioplastia de Balón/instrumentación , Arteria Ilíaca , Metales , Enfermedad Arterial Periférica/terapia , Placa Aterosclerótica , Stents , Anciano , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Femenino , Alemania , Humanos , Arteria Ilíaca/diagnóstico por imagen , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Diseño de Prótesis , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
7.
J Vasc Surg ; 69(3): 671-679.e1, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30528403

RESUMEN

OBJECTIVE: The objective of this study was to evaluate outcomes of endovascular treatment of aortic coarctation in adults. METHODS: Clinical data and imaging studies of 93 consecutive patients treated at nine institutions from 1999 to 2015 were reviewed. We included newly diagnosed aortic coarctation (NCO), recurrent coarctation, and aneurysmal/pseudoaneurysmal degeneration (ANE) after prior open surgical repair (OSR) of coarctation. Primary end points were morbidity and mortality. Secondary end points were stent patency and freedom from reintervention. RESULTS: There were 54 (58%) male and 39 (42%) female patients with a mean age of 44 ± 17 years. Thirty-two patients had NCO (mean age, 48 ± 16 years) and 61 had endovascular reinterventions after prior OSR during childhood (mean, 30 ± 17 years after initial repair), including 50 patients (54%) with recurrent coarctation and 11 (12%) with ANE. Clinical presentation included asymptomatic in 31 patients (33%), difficult to control hypertension in 42 (45%), and lower extremity claudication in 20 (22%). Endovascular treatment was performed using balloon-expandable covered stents in 47 (51%) patients, stent grafts in 36 (39%) patients, balloon-expandable uncovered stents in 9 (10%) patients, and primary angioplasty in 1 (1%) patient. Mean lesion length and diameter were 64.5 ± 50.6 mm and 19.5 ± 6.7 mm, respectively. Mean systolic pressure gradient decreased from 24.0 ± 17.5 mm Hg to 4.4 ± 7.4 mm Hg after treatment (P < .001). Complications occurred in nine (10%) patients, including aortic dissections in three (3%) patients and intraoperative ruptures in two patients; type IA endoleak, renal embolus, spinal headache, and access site hemorrhage occurred in one patient each. The aortic dissections and ruptures were treated successfully by deploying an additional covered stent proximal to the site of dissection or rupture. Two patients died within 30 days of the index procedure. After a mean follow-up of 3.2 ± 3.1 years, nearly all patients (98%) were clinically improved and all stents were patent. Reintervention was needed in 10 (11%) patients. Freedom from reintervention at 5 years was 85%. Two additional patients died during follow-up of coarctation-related causes, including rupture of an infected graft and visceral ischemia. Patient survival at 5 years was 89%. CONCLUSIONS: Endovascular repair is effective with an acceptable safety profile in the treatment of NCO and postsurgical complications of coarctation after initial OSR. Aortic rupture is an infrequent (2%) but devastating complication with high mortality. Balloon-expandable covered stents are preferred for NCO, whereas stent grafts are used for ANE. The rate of reinterventions is acceptable, with high procedural and long-term clinical success.


Asunto(s)
Angioplastia de Balón , Coartación Aórtica/terapia , Implantación de Prótesis Vascular , Adulto , Anciano , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Coartación Aórtica/diagnóstico por imagen , Coartación Aórtica/mortalidad , Coartación Aórtica/fisiopatología , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Femenino , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/fisiopatología , Oclusión de Injerto Vascular/terapia , Humanos , Masculino , Persona de Mediana Edad , Supervivencia sin Progresión , Recurrencia , Retratamiento , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Stents , Factores de Tiempo , Grado de Desobstrucción Vascular , Adulto Joven
8.
J Vasc Surg ; 66(6): 1638-1643, 2017 12.
Artículo en Inglés | MEDLINE | ID: mdl-28602624

RESUMEN

OBJECTIVE: The introduction of lower profile endografts expanded the application of aortic endovascular repair. However, evidence about their durability is still scarce. The objective of this study was to assess longer term durability of the Zenith Alpha Thoracic Stent Graft (Cook Inc, Bloomington, Ind) after thoracic endovascular aortic repair. METHODS: Prospectively collected data of all patients treated for thoracic aortic aneurysms or penetrating aortic ulcers and having computed tomography angiography-based follow-up of ≥12 months were retrospectively analyzed. The primary end point was ongoing clinical success. Among the secondary end points, stent graft migration and fracture were analyzed. RESULTS: Between August 2010 and October 2015, 70 consecutive patients were treated in a single center with the Zenith Alpha stent graft. With computed tomography angiography-based follow-up of 22.3 ± 15.9 months, ongoing clinical success was 87.1%. There were three cases of type IA endoleak (4.3%), two cases of type IB endoleak (2.9%), and one case of aneurysm sac enlargement (1.4%). Five patients died postoperatively (7.1%). No type III or type IV endoleak was detected; there was one case of distal stent graft migration and no stent fracture. Reintervention was necessary in one case (1.4%) of a combined type IA and type II endoleak. There were no conversions to open repair and no ruptures or intraoperative deaths. All-cause mortality was 17.1% at 76 months. CONCLUSIONS: The Zenith Alpha Thoracic Stent Graft appears to maintain favorable results in a longer time frame with a low incidence of aneurysm sac growth and migration. Results from multicenter prospective trials are needed to validate these data.


Asunto(s)
Aneurisma de la Aorta Torácica/cirugía , Enfermedades de la Aorta/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Úlcera/cirugía , Anciano , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Enfermedades de la Aorta/diagnóstico por imagen , Enfermedades de la Aorta/mortalidad , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Angiografía por Tomografía Computarizada , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Migración de Cuerpo Extraño/etiología , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Diseño de Prótesis , Falla de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Úlcera/diagnóstico por imagen , Úlcera/mortalidad
9.
Ann Vasc Surg ; 40: 120-127, 2017 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-27890848

RESUMEN

BACKGROUND: The INCRAFT system is a new device that has become available in Europe in September 2014 after the announcement of the 2-year results of the INNOVATION trial. However, no data in the "real-world" practice exist. Herein, we report our early series of consecutive patients treated with the INCRAFT after its launch on the market. METHODS: Prospectively collected data of patients enrolled in the INNOVATION trial (group IT) and consecutive patients from CE Mark approval to April 2015 (group CM) were retrospectively evaluated and compared. Main outcomes were any device- or procedure-related major adverse event (MAE) within 30 days and survival and reinterventions during follow-up. RESULTS: Seventeen patients were included in group IT (median follow-up [95% CI]; 60.4 months [55-63]), and 24 patients were in group CM (12.5 [6.6-13.5]). The patients' comorbidities were comparable between the groups. The average diameter of aortic bifurcation and the bilateral external iliac arteries was significantly smaller in group CM. Adjunctive interventions for iliac artery disease were performed in 8 patients (33%) in group CM, whereas no adjunctive was required in group IT. MAEs within 30 days were not significantly different between 2 groups. Survival and reintervention rates were also equivalent after a median follow-up of 13 months. CONCLUSIONS: Compared to our patients recruited for the INNOVATION trial, the patients after CE Mark approval had significantly more challenging access routes reflecting the difficulties of "real-world" conditions. Despite frequent adjunctive procedures in group CM, the early performance of the endograft was encouraging so far. Long-term surveillance of those patients remains mandatory.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Anciano de 80 o más Años , Angiografía , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Ensayos Clínicos como Asunto , Supervivencia sin Enfermedad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico por imagen , Complicaciones Posoperatorias/etiología , Vigilancia de Productos Comercializados , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
10.
J Endovasc Ther ; 22(2): 153-9, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25809352

RESUMEN

PURPOSE: To assess safety and short-term efficacy of endovascular repair of the thoracic aorta with the new Zenith Alpha stent-graft. METHODS: Between August 2010 and May 2014, 33 patients (21 men; mean age 73.2±9.0 years) were treated Zenith Alpha stent-graft (group ZA). Outcomes of this group were compared with those of 34 patients (25 men; mean age 70.3±8.5 years) treated contemporaneously with the Zenith TX-2 for the same pathologies (group TX). The primary outcome measure was technical success. Data on iliac tortuosity, minimum access vessel diameter, and previous unsuccessful treatment with other endografts was also recorded. RESULTS: Technical success was 93.9% in group ZA and 91.2% in group TX (p=0.67). There was no case of surgical death or conversion to open repair in either group. Two (6%) type I endoleaks occurred in group ZA and 3 (9%) in group TX (p=0.67). Three patients died within 30 days in group ZA vs. none in group TX (p=0.07). Mean minimum access vessel diameter was significantly smaller (5.07 vs. 6.65 mm, p=0.002) and iliac tortuosity indices significantly higher in group ZA (1.34 vs. 1.25, p=0.02). Access vessel complications occurred in 1 (3%) patient in group ZA and 4 (12%) patients in group TX (p=0.17). Significantly more patients in group ZA (6, 18%) were unsuccessfully treated previously with other endografts vs. none in group TX (p=0.01). CONCLUSION: The new Zenith Alpha appears to be equally as safe and efficacious as the Zenith TX-2 while being used in patients with demanding access vessel morphology.


Asunto(s)
Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Anciano de 80 o más Años , Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
11.
Cardiovasc Intervent Radiol ; 46(2): 268-273, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36526800

RESUMEN

PURPOSE: Pseudoaneurysm (PSA) developing after catheter examinations is one of the most frequent vascular complications and a nonsurgical technique with utmost low risk of complications is warranted. Our aim was to investigate the technical feasibility, success, and safety of transaneurysmal occlusion of complicated post-interventional common femoral artery (CFA) PSA using the Angio-Seal Closure Device (ASCD) and a technique that we describe as the transaneurysmal (TA) maneuver. MATERIAL AND METHODS: We used the Angio-Seal (Terumo, Tokyo, Japan) Closure System to manage complicated PSAs in patients who would otherwise have needed surgery after failure of all conservative therapies. The TA maneuver was performed in 14 consecutive patients from July 2021 to July 2022. After ultrasound-guided puncture of the PSA close to its neck, the CFA was entered radiographically with micro-guidewires, and the neck of the PSA was closed with the ASCD after changing the sheaths and wires. All patient had to wear a pressure dressing until the next day, when successful closure was verified by sonography. RESULTS: All procedures were performed with technical success and without any complications. No patient had to undergo surgery. All sonographies on the next day confirmed complete absence of perfusion within the PSA and normal flow conditions of the CFA and vessels below. CONCLUSION: The TA maneuver a promising minimally invasive procedure for closing complicated PSA of the CFA after catheter examination.


Asunto(s)
Aneurisma Falso , Humanos , Aneurisma Falso/diagnóstico por imagen , Aneurisma Falso/terapia , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/cirugía , Técnicas Hemostáticas , Punciones , Japón , Resultado del Tratamiento
13.
J Endovasc Ther ; 17(2): 137-50, 2010 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-20426628

RESUMEN

PURPOSE: To assess early and midterm outcomes after thoracic endovascular aortic repair (TEVAR) with the Valiant Thoracic Stent Graft. METHODS: Data were reviewed retrospectively for 92 patients (69 men; mean age 65+/-14.5 years) who underwent TEVAR in 52.2% elective and 47.8% urgent/emergent procedures for treatment of 56 degenerative aneurysms, 32 aortic dissections, and 4 traumatic injuries at 4 German centers between June 2005 and March 2008. RESULTS: The technical success rate was 86.9%. Through 30 days, there were 3 (3.3%) deaths. Periprocedural complications included endoleak (n = 6), systemic complications (n = 6), arterial rupture or dissection (n = 6), device-related complications (n = 5), retrograde aortic dissection (n = 1), aortic rupture (n = 1), spinal cord ischemia (n = 1), and stroke (n = 1). Cumulative survival was 95.5% at 1 year, 87.4% at 2 years, and 76.4% at 3 years. The rate of aneurysm-related mortality was 2.2% (n = 2). For aneurysm and dissection patients, respectively, the rates of major complications were 9.3% and 15.6%, and secondary procedures were required in 7.4% and 12.5%. Type I endoleaks were detected in 4 aneurysm and 2 dissection patients, and graft migration occurred in 1 patient each from the aneurysm and dissection groups. No patients were converted to open surgery during follow-up. Aortic diameter reduction >5 mm was confirmed for 58.4% of patients overall. CONCLUSION: The high technical and clinical success, the low all-cause and aneurysm-related mortality, the negligible rates of neurological complications and spinal cord ischemia, and the low incidence of endoleak support the safety and effectiveness of TEVAR with the Valiant Thoracic Stent Graft. However, some deployment-related complications could be avoided by enhancements of the deployment mechanism.


Asunto(s)
Angioplastia , Aorta Torácica , Enfermedades de la Aorta/terapia , Implantación de Prótesis Vascular , Prótesis Vascular , Stents , Adolescente , Adulto , Anciano , Enfermedades de la Aorta/etiología , Enfermedades de la Aorta/patología , Niño , Estudios de Cohortes , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Estudios Retrospectivos , Resultado del Tratamiento , Adulto Joven
14.
J Endovasc Ther ; 16(6): 708-13, 2009 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-19995109

RESUMEN

PURPOSE: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. METHODS: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72+/-6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). RESULTS: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n = 16) or late (n = 7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p<0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p<0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p<0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p<0.05). Obesity was not a risk factor for any complication. CONCLUSION: Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. Anterior wall calcification and severe fibrosis of the access vessel are also predictors of primary failure, whereas obesity and sheath size are not.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/métodos , Cateterismo Periférico , Arteria Femoral , Hemorragia/prevención & control , Técnicas Hemostáticas/instrumentación , Anciano , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Cateterismo Periférico/efectos adversos , Competencia Clínica , Estudios de Factibilidad , Femenino , Hemorragia/etiología , Técnicas Hemostáticas/efectos adversos , Humanos , Masculino , Oportunidad Relativa , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Diseño de Prótesis , Punciones , Medición de Riesgo , Factores de Riesgo , Stents , Insuficiencia del Tratamiento
15.
J Cardiovasc Surg (Torino) ; 57(5): 712-5, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27406396

RESUMEN

Use of endovascular means is gaining ever greater acceptance in the treatment of aorto-iliac aneurysms. Especially, the treatment of patients with common iliac aneurysms (CIAs) may be very challenging due to the complexity of the underlying disease with often involvement of the hypogastric artery. Additionally, the variety of endovascular therapeutic options such as the use of iliac branch devices, parallel grafts, the bell-bottom technique or coil embolization of the hypogastric artery and overstenting of the origin represents significant limitation regarding the presentation of a clear and robust endovascular therapeutic algorithm. Aim of the present article was the demonstration of the institutional experience with the endovascular management of CIAs in order to provide a clinical recommendation and algorithm.


Asunto(s)
Algoritmos , Implantación de Prótesis Vascular , Vías Clínicas , Procedimientos Endovasculares , Aneurisma Ilíaco/cirugía , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Humanos , Aneurisma Ilíaco/diagnóstico por imagen , Diseño de Prótesis , Factores de Riesgo , Stents , Resultado del Tratamiento
16.
J Vasc Surg ; 38(1): 78-82, 2003 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-12844093

RESUMEN

PURPOSE: To evaluate safety and cost benefits of the percutaneous technique for treatment of aortic aneurysm, a prospective randomized study was performed that compared the endovascular suture technique with conventional cutdown access and repair. MATERIALS AND METHODS: From January 2002 through July 2002, 30 endografts, including 14 Talent stent-grafts (Medtronic, Sunrise, Fla) and 16 Zenith endografts (Cook, Bloomington, Ind) were implanted in 30 patients for endovascular aneurysm treatment. The patients were randomized to either percutaneous technique (group A) or conventional cutdown (group B). Fifty-five femoral arteries were cannulated with large-bore (14F-25F) introducers and were included in the study. Safety and efficiency of both techniques were assessed by recording the complication rates, operation time, discharge, and time to ambulation. Comparison of selected estimated costs included both variable and fixed costs for femoral access and expenses for treatment of complications. RESULTS: No operative deaths occurred. The complication rates were similar and included 1 arterial thrombosis in each group, 3 lymphoceles in group B, and 1 conversion to cutdown because of bleeding in group A. Mean surgery time (86.7 +/- 27 minutes vs 107.8 +/- 38.5 minutes; P <.05) and time to ambulation (20.1 +/- 4.3 hours vs 33.1 +/- 18.4 hours; P <.001) were significantly shorter in the group treated percutaneously. Because of the cost of the closure device, total cost of the percutaneous technique averaged 99.2 euro; more than cutdown. CONCLUSIONS: The percutaneous technique decreases the invasiveness of endovascular therapy of aortic aneurysm and reduces operative time and time to ambulation. Complications were roughly equivalent in severity. The additional cost for the device appears to justify its use for this form of aneurysm treatment.


Asunto(s)
Angioplastia/métodos , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/métodos , Técnicas de Sutura , Anciano , Anciano de 80 o más Años , Angioplastia/economía , Aneurisma de la Aorta Torácica/cirugía , Análisis Costo-Beneficio , Femenino , Arteria Femoral/cirugía , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Estudios Prospectivos , Stents , Resultado del Tratamiento
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