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1.
Artículo en Inglés | MEDLINE | ID: mdl-39283297

RESUMEN

Thoracic endovascular aortic repair is commonly used in the surgical treatment of patients with aortic coarctation, but complications such as endoleaks can occur. This video tutorial presents a case study involving the exclusion of a stent graft from the bloodstream through total transection of the aortic arch and abdominal aorta, with off-pump aortic grafting and debranching of the left carotid and subclavian arteries.


Asunto(s)
Implantación de Prótesis Vascular , Endofuga , Procedimientos Endovasculares , Humanos , Endofuga/etiología , Endofuga/cirugía , Endofuga/diagnóstico , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/efectos adversos , Implantación de Prótesis Vascular/métodos , Implantación de Prótesis Vascular/efectos adversos , Masculino , Aorta Abdominal/cirugía , Stents , Aorta Torácica/cirugía , Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico
2.
Sci Prog ; 107(3): 368504241274998, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39252493

RESUMEN

OBJECTIVE: To evaluate the mid-term outcomes of different treatment strategies for the internal iliac artery (IIA) during EVAR. METHODS: This was a retrospective study. All patients undergoing EVAR, who required treatment of at least one side of IIA from January 2013 to July 2022 in a single center, were included. According to the different treatment strategies for IIA, the patients were divided into UP (unilateral preservation), BP (bilateral preservation) and BE (bilateral embolization) groups. The primary outcomes included buttock claudication, bowel ischemia and iliac-related reintervention. Then patients who underwent IIA reconstruction were divided into IPG (iliac parallel stent graft) and IBG (iliac branch stent graft) groups according to the reconstruction technique. The primary outcomes included endoleak, iliac branch occlusion and iliac-related reintervention. RESULTS: A total of 237 patients were included, including 167 in the UP group, 9 in the BP group and 61 in the BE group. The mean follow-up time was 39.0 ± 27.7, 50.0 ± 22.1 and 25.8 ± 18.9 months in UP, BP and BE groups, respectively. Thirty cases (12.7%) of buttock claudication occurred, and it was significantly higher in the BE group than the UP group (26.2% vs. 7.8%, p < 0.001). There were no significant differences in the other follow-up outcomes among three groups. The K-M analysis indicated that the patients in the BE group had a lower survival rate than those in the other two groups (p = 0.024). 24 patients underwent IIA reconstruction, including 8 in the IPG group and 16 in the IBG group. The endoleak in the IBG group was significantly lower than that in the IPG group (0% vs. 25.0%, p = 0.041). The iliac-related reintervention, iliac occlusion and mortality were similar between the two groups. CONCLUSION: Overall it is beneficial for patients to preserve at least one side of IIA during EVAR as much as possible. Compared with IPG, IBG might be more applicable for IIA reconstruction.


Asunto(s)
Procedimientos Endovasculares , Arteria Ilíaca , Humanos , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/efectos adversos , Masculino , Femenino , Anciano , Arteria Ilíaca/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Stents , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/métodos , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma Ilíaco/cirugía , Endofuga/cirugía , Endofuga/etiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Embolización Terapéutica/métodos , Reparación Endovascular de Aneurismas
3.
J Cardiothorac Surg ; 19(1): 416, 2024 Jul 03.
Artículo en Inglés | MEDLINE | ID: mdl-38961402

RESUMEN

BACKGROUND: The occurrence of type II endoleaks after endovascular repair of aortic aneurysm has gradually gained increasing attention. We present a case of a patient with an expanding aneurysm after thoracic endovascular aortic repair (TEVAR) for a type II endoleak, in which successful direct ligations of the intercostal artery were performed using a sac incision without cardiopulmonary bypass (CPB) or graft replacement. CASE PRESENTATION: A 62-year-old male patient, previously treated with TEVAR for a descending thoracic aortic aneurysm, presented with ongoing chest discomfort. Based on the diagnosis of a growing aneurysm and type II endoleak, the patient was prepared for CPB and aortic cross-clamping, as a precautions against the possibility of a type I endoleak. A longitudinal opening of the thoracic aortic aneurysm sac was performed following left thoracotomy. Visual confirmation identified the T5 level intercostal artery as the source of the endoleak, and after confirming the absence of a type I endoleak, multiple ligations were applied to the intercostal artery. Follow-up computed tomography confirmed the absence of endoleaks or sac growth. CONCLUSION: In a case involving TEVAR for a thoracic aortic aneurysm, open suture ligations were used to treat type II endoleaks without having to resort to CPB, resulting in successful outcomes.


Asunto(s)
Aneurisma de la Aorta Torácica , Endofuga , Procedimientos Endovasculares , Humanos , Masculino , Endofuga/cirugía , Endofuga/etiología , Persona de Mediana Edad , Aneurisma de la Aorta Torácica/cirugía , Procedimientos Endovasculares/métodos , Implantación de Prótesis Vascular/métodos , Implantación de Prótesis Vascular/efectos adversos , Tomografía Computarizada por Rayos X , Aorta Torácica/cirugía , Ligadura , Reparación Endovascular de Aneurismas
4.
Ann Vasc Surg ; 108: 239-245, 2024 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-38942365

RESUMEN

BACKGROUND: Late open conversion (LOC) following endovascular aneurysm repair (EVAR) is a rare complication with a high morbidity and mortality and is often proposed as the last line of treatment after failure of endovascular reintervention of any type. This study aimed to highlights the limitations of EVAR follow-up imaging in characterizing endoleaks, which may contribute to the failure of endovascular reinterventions and lead to LOC. METHODS: This retrospective cohort study recruited all EVAR implanted in Amiens University Hospital (France) between January 2008 and December 2022. Elective LOC was defined as surgical conversion >1 month after EVAR. The primary endpoint was the rate of wrong categorization of endoleaks by follow-up exams before LOC. Secondary endpoints were the morbidity and the mortality associated with LOC. RESULTS: Seven hundred eight EVARs were performed in our institution, 30 required elective LOC. Twenty-five of them were treated for sac enlargement due to an endoleak (83.3%) (all types). Wrong categorization of the endoleak was noted in 13 patients (52.2%). Twelve of these recategorizations involved the preoperative diagnosis of a type II endoleaks (92.3%). The change in categorization in 7 out of 12 cases (58%) was in favor of a type I endoleak, other recategorization included 1 type III (8%) and 4 type IV (33%). One patient died during the 30-day postoperative period and 7 patients (28%) presented a major complication; the median length of stay was 13 days (interquartile range 9-21). CONCLUSIONS: Routine follow-up examinations such as angioscanner and contrast Doppler ultrasound appear to be limited in their ability to categorize the type of persistent endoleak, which may increase the number of patients requiring LOC. New precision diagnostic imaging techniques, such as dynamic examinations, need to be developed to limit the need for LOC.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Conversión a Cirugía Abierta , Endofuga , Procedimientos Endovasculares , Valor Predictivo de las Pruebas , Humanos , Estudios Retrospectivos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Endofuga/etiología , Endofuga/diagnóstico por imagen , Endofuga/cirugía , Masculino , Femenino , Anciano , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Implantación de Prótesis Vascular/instrumentación , Factores de Tiempo , Anciano de 80 o más Años , Francia , Factores de Riesgo , Resultado del Tratamiento , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Conversión a Cirugía Abierta/efectos adversos
5.
Ann Vasc Surg ; 106: 196-204, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38810725

RESUMEN

BACKGROUND: Endovascular aortic repair (EVAR) has become the standard of care for patients with infrarenal aortic aneurysms over the last 2 decades. Endograft technology and treatment of complications like endoleaks, graft migration, or graft occlusion developed over time. However, sometimes open surgical conversion maybe required. Our aim was to analyze the indications, the technical aspects and outcomes in patients who underwent open conversion after EVAR with different types and generations of endografts. METHODS: This retrospective single-center study reviewed all patients who underwent EVAR from 2004 to 2020. Open surgical conversions >1 month post EVAR were identified. Conversions for graft infection were excluded. Indications for conversion and operative technique were analyzed. Primary endpoint of the study was 30-day mortality. Secondary endpoints were re-interventions and follow-up mortality. RESULTS: During 2004 and 2020, 443 consecutive EVARs were performed, and 28 patients required open surgical conversion, with an additional 3 referred from other hospitals (N = 31). The median age was 75 (range 58-93); 94% were male. Conversion was performed after a median time of 55 months (range 16-209). Twenty patients underwent elective and 11 emergency conversion. Indications for open conversion were graft migration, respectively, disease progression with endoleak type Ia and/or Ib in 52% (16/31) and sac expansion due to endoleak type II in 26% (8/31). Of the 31 patients, 17 (55%) had at least one previous endovascular re-intervention. All patients met the device-specific instructions for use for each implanted endograft. In-hospital intervention rate was 16% (5/31). Thirty-day mortality rate was 3% (1/31) with one patient died due to multiorgan failure after rupture with complete endograft replacement. Five patients (16%) died during follow-up. Mid-term follow-up was 47.5 months (range 24-203) with estimated cumulative survival rates of 97%, 89%, and 84%, at 1, 3, and 5 years, respectively. CONCLUSIONS: Late open conversion remains a valuable treatment option and can be performed safely in elective and emergency setting with a low early mortality. Lifelong surveillance and prompt intervention when necessary are essential in ensuring optimal outcomes after EVAR and preventing the need for emergent conversions.


Asunto(s)
Aneurisma de la Aorta Abdominal , Prótesis Vascular , Conversión a Cirugía Abierta , Reparación Endovascular de Aneurismas , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Conversión a Cirugía Abierta/efectos adversos , Endofuga/etiología , Endofuga/cirugía , Endofuga/mortalidad , Reparación Endovascular de Aneurismas/efectos adversos , Reparación Endovascular de Aneurismas/instrumentación , Reparación Endovascular de Aneurismas/mortalidad , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/cirugía , Complicaciones Posoperatorias/etiología , Diseño de Prótesis , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
8.
J Vasc Surg ; 80(3): 612-620, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38604322

RESUMEN

OBJECTIVE: The aim of this study was to update our earlier experience and to evaluate long-term outcomes of chimney endovascular aortic repair performed for selected cases with complex abdominal aortic aneurysm. METHODS: A single-center retrospective cohort study was conducted on 51 consecutive patients who underwent chimney endovascular aortic repair procedure, deemed unfit for open surgical repair and fenestrated endovascular aneurysm repair, from October 2009 to November 2019. Kaplan-Meier analyses were used to assess the estimated overall survival, freedom from aneurysm related mortality, freedom from reintervention, freedom from target vessel instability, and freedom from type Ia endoleaks. RESULTS: Fifty-one patients (mean age, 77.1 ± 7.5 years) with a mean preoperative maximum aneurysm diameter of 74.2 ± 20.1 mm were included. Mean follow-up duration was 48.6 months (range, 0-136 months). Estimated overall survival at 5 and 7 years was 36.3% ± 7.1% and 18.3% ± 6.0%, respectively. Freedom from aneurysm-related mortality was 88.6% ± 4.9% at 7 years. Estimated freedom from type Ia endoleaks at 7 years was 91.8% ± 3.9%. A total of 21 late reinterventions were performed in 17 patients (33%). Most of them were performed to treat type II endoleaks with sac growth (47.6%; n = 10) and type Ib endoleak (23.8%; n = 5). Estimated freedom from reintervention at 7 years was 56.3% ± 7.9%. Estimated freedom from target vessel instability at 7 years was 91.5% ± 4.1%. CONCLUSIONS: The 7-year results of chimney endovascular aortic repair procedures performed in our center confirm the long-term safety and effectiveness of this technique in a series of high-risk patients with large aneurysms. The present study has, to the best of our knowledge, the longest follow-up for patients treated with chimney endovascular aortic repair, and it provides data to the scarce literature on the long-term outcomes of this procedure, showing acceptable to good long-term results.


Asunto(s)
Aneurisma de la Aorta Abdominal , Reparación Endovascular de Aneurismas , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Prótesis Vascular , Endofuga/etiología , Endofuga/cirugía , Reparación Endovascular de Aneurismas/efectos adversos , Reparación Endovascular de Aneurismas/mortalidad , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
9.
Eur J Vasc Endovasc Surg ; 68(1): 40-48, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38490356

RESUMEN

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Diseño de Prótesis , Sistema de Registros , Humanos , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Masculino , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Anciano , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/métodos , Estudios Prospectivos , Resultado del Tratamiento , Anciano de 80 o más Años , Factores de Tiempo , Stents , Endofuga/etiología , Endofuga/cirugía , Países Bajos , Factores de Riesgo , Alemania , Bélgica
12.
Kyobu Geka ; 77(2): 136-139, 2024 Feb.
Artículo en Japonés | MEDLINE | ID: mdl-38459863

RESUMEN

A 67-year-old male was admitted to our hospital for sudden onset chest pain and hoarseness. He underwent 2-debranching thoracic endovascular aortic repair for a ruptured aortic arch aneurysm four years prior. However, computed tomography (CT) revealed an aneurysmal rerupture due to a typeⅠa endoleak. We performed partial arch replacement with uncovered stent removal under intermittent hypothermic circulatory arrest. We needed to be more careful than usual open heart surgery because a non-anatomical bypass procedure was performed. The surgery was successful without any major complications, and the patient was discharged on the 23th postoperative day. Reinterventions post-endovascular repair are sometimes difficult;thus, open surgery could be useful for arch replacement.


Asunto(s)
Aneurisma del Arco Aórtico , Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Anciano , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/cirugía , Reparación Endovascular de Aneurismas , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/complicaciones , Implantación de Prótesis Vascular/efectos adversos , Stents/efectos adversos , Resultado del Tratamiento , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Prótesis Vascular/efectos adversos , Estudios Retrospectivos
13.
Expert Rev Med Devices ; 21(3): 165-177, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38431273

RESUMEN

INTRODUCTION: With the incidence of thoracic aortic disease on the rise, total arch replacement (TAR) with frozen elephant trunk (FET) remains the gold-standard management strategy due to optimal results. Several FET devices exist commercially on the global market. However, the mainstay and most commonly used and reported device is the Thoraflex Hybrid Prosthesis (THP), with several recent reports suggesting its superiority. AREAS COVERED: This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy, and graft kinking. In addition, the design features of THP is discussed, and an overview of market competitors is also highlighted. EXPERT OPINION: THP consistently demonstrates its effectiveness in treating complex thoracic aortic pathology through favorable clinical outcomes, which can be attributed to its unique and innovative design. Rates of early mortality ranged 0.6-14.2%, neurological complications 0-25%, endoleak 0-8.4% and dSINE 0-14.5%, with minimal incidence of graft kinking and coagulopathy. Aortic remodeling is favorable and comparable to competitors. All this evidence solidifies THP as the leading FET device, particularly when combined with appropriate patient selection and surgical planning.


Asunto(s)
Disección Aórtica , Implantación de Prótesis Vascular , Humanos , Prótesis Vascular , Endofuga/cirugía , Stents , Aorta Torácica/cirugía , Estudios Retrospectivos , Resultado del Tratamiento
14.
J Vasc Surg ; 79(6): 1369-1378, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38316346

RESUMEN

OBJECTIVE: There are a variety of methods used today to treat common iliac aneurysms with endovascular techniques. Of these approaches, little is known about whether a particular limb strategy influences endoleak, reintervention, or aneurysm regression rates. We present 5-year data comparing endoleak, stent graft migration, fracture, aneurysm sac dynamics, and aortic rupture rates among patients treated with bell bottom limbs (BB), iliac branch endoprosthesis (IBE), and coil and cover (CC) approaches from the Global Registry for Endovascular Aortic Treatment registry. Secondary end points were all-cause mortality, stroke, reintervention, and paraplegia. METHODS: Subjects from the GORE Global Registry for Endovascular Aortic Treatment were enrolled over a 5-year period from October 2017 to August 2022. We included 924 subjects in this study. Statistical data was generated on R software and limb groups were compared using the Pearson's χ2 test and the Kruskal-Wallis rank-sum test. RESULTS: We found no statistical difference in endoleak rates, stent graft migration, fracture, or aortic rupture when stratified by limb strategy. There was no difference between limb approaches with regard to aneurysm sac dynamics among those with abdominal aortic aneurysms and common iliac aneurysms. Similarly, no statistical difference between limb strategies was found in all-cause mortality, stroke, paraplegia, or reintervention rates. Among patients that required an additional graft during reintervention, the highest rates were found within the IBE group 8.6%, compared with BB group 2.2% and CC group 1.3% (P = .006). CONCLUSIONS: Overall, there was no difference among limb strategies in endoleak rates, stent graft migration, aneurysm sac dynamics, aortic rupture rates, or our secondary end points. Increased rates of reintervention requiring an additional graft within the IBE group is noteworthy and must be weighed against the adverse effects of hypogastric sacrifice with the CC approach or potentially less advantageous seal zones in the BB approach. This finding suggests that all limb approaches have equivalent effectiveness in managing the aneurysmal common iliac artery; thus, the choice of limb strategy should be individualized and remain at physician discretion. Future research should include a more robust sample size to reproduce these findings.


Asunto(s)
Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Aneurisma Ilíaco , Diseño de Prótesis , Sistema de Registros , Stents , Humanos , Aneurisma Ilíaco/cirugía , Aneurisma Ilíaco/mortalidad , Aneurisma Ilíaco/diagnóstico por imagen , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Masculino , Femenino , Resultado del Tratamiento , Factores de Tiempo , Anciano , Factores de Riesgo , Endofuga/etiología , Endofuga/cirugía , Anciano de 80 o más Años , Rotura de la Aorta/cirugía , Rotura de la Aorta/mortalidad , Rotura de la Aorta/diagnóstico por imagen , Falla de Prótesis , Estudios Retrospectivos , Medición de Riesgo , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Migración de Cuerpo Extraño/etiología
15.
J Surg Res ; 296: 516-522, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38330677

RESUMEN

INTRODUCTION: Recent data suggests that infrarenal abdominal aortic aneurysm (AAA) endovascular repair (EVAR) with large diameter grafts (LGs) may have a higher risk of endoleak and reintervention. However, this has not been studied extensively for fenestrated endovascular aneurysm repair (fEVAR). We, therefore, sought to evaluate the outcomes of patients undergoing fEVAR with large-diameter endografts. METHODS: Patients from the national Vascular Quality Initiative registry who underwent fEVAR for intact juxtarenal AAA were identified. Patients with genetic causes for aneurysms, those with prior aortic surgery, and those undergoing repair for symptomatic or ruptured aneurysms were excluded. Rates of endoleaks and reintervention at periprocedural and long-term follow-up timepoints (9-22 mo) were analyzed in grafts 32 mm or larger (LG) and were compared to those smaller than 32 mm (small diameter graft). RESULTS: A total of 693 patients (22.8% LG) were identified. Overall, demographic variables were comparable except LG exhibited a more frequent history of coronary artery disease (32.9% versus 25.4%, P = 0.037). There were no significant differences in the rates of endoleak at procedural completion. Overall survival at 5 y was no different. The rate of reintervention at 1 y was also no different (log-rank P = 0.86). CONCLUSIONS: While graft size appears to have an association with outcomes in infrarenal aneurysm repair, the same does not appear to be true for fEVAR. Further studies should evaluate the long-term outcomes associated with LG which could alter the approach to repair of AAA with large neck diameters traditionally treated with standard infrarenal EVAR.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Endofuga/etiología , Endofuga/cirugía , Resultado del Tratamiento , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Estudios Retrospectivos , Diseño de Prótesis
16.
J Vasc Surg ; 79(5): 1090-1100.e4, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38185214

RESUMEN

OBJECTIVE: To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. METHODS: Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. RESULTS: Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was -28.8% (95% CI, -35.3 to -22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was -5.9 mm (95% CI, -7.5 to -4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. CONCLUSIONS: Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Femenino , Prótesis Vascular , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/etiología , Estudios Prospectivos , Implantación de Prótesis Vascular/efectos adversos , Reparación Endovascular de Aneurismas , Estudios de Seguimiento , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Estudios Retrospectivos , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/cirugía , Factores de Riesgo
19.
Vasc Endovascular Surg ; 58(2): 151-157, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37607586

RESUMEN

PURPOSE: To evaluate the safety and effectiveness of intra-sac thrombin injection to remedy type II endoleaks (T2ELs) during endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: 224 cases abdominal aortic aneurysm (AAA) were treated with EVAR. For the 52 cases of intra-operative type II endoleaks and 8 cases of ruptured AAAs, after the grafts were deployed, thrombin was injected into the aneurysm sac through a preset catheter. The occurrence of endoleaks post-EVAR were followed up with by Computed Tomography (CT) angiogram. The diameter and the volume of the aneurysm sac were also measured. Endpoints included incidence of T2ELs, AAA sac shrinkage and re-intervention rate and all-cause mortality. RESULTS: The overall technical success rate was 100%. Fifty-two patients were followed up with for 9-56 (median 24) months. No serious complications were observed during follow-up. The incidence of endoleak was 5.8% (3/52) during follow-up. The maximum diameter of the aneurysm decreased from 61.1 ± 14.2 mm to 53.7 ± 10.6 mm, 47.9 ± 8.3 mm and 43.7 ± 7.2 mm (87.9%, 78.4% and 71.5% of pre-EVAR) at the 6-month, 1-year and 2-year follow-up, respectively (P < .05). The volume of the aneurysm sac shrank from 236.2 ± 136.2 cm3 to 202.6 ± 114.1 cm3, 155.6 ± 68.4 cm3 and 129.7 ± 52.4 cm3 (85.8%, 65.9%, and 54.9% of pre-EVAR) at the 6-month, 1-year and 2-year follow-up, respectively (P < .05). The rate of various endoleaks was 5.8% (3/52) and the re-intervention rate was 1.9% (1/52) in this research. CONCLUSIONS: Clinical outcomes show that intra-sac injection of thrombin during EVAR is safe and may be effective in remedying small amount and low-velocity endoleaks and promoting shrinkage of the aneurysm sac.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/cirugía , Reparación Endovascular de Aneurismas , Trombina/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Factores de Riesgo , Estudios Retrospectivos
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