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1.
J Endovasc Ther ; : 15266028241284364, 2024 Oct 06.
Artículo en Inglés | MEDLINE | ID: mdl-39369322

RESUMEN

INTRODUCTION: To confirm real-world clinical practice results reported with anatomically fixed bifurcated endograft, a physician-initiated study was designed-AFX2-LIVE registry. MATERIALS AND METHODS: From November 2019 to August 2021, investigators enrolled all consecutive patients treated with AFX2 (Endologix Inc., Irvine, CA, USA) endograft. Patients with abdominal aortic aneurysms (AAAs), penetrating aortic ulcers (PAU), and isolated infrarenal aortic dissections were included. Clinical and anatomical data, including baseline, intraoperative, and in-hospital details, as well as follow-up data, were collected in an anonymized prospectively compiled database. The primary endpoint of this study was to evaluate the technical and clinical success of endovascular aortic repair (EVAR) using AFX2 endograft. RESULTS: A total of 535 patients were enrolled from 43 Italian and Spanish centers and analyzed according to the protocol. Four hundred eighty-nine patients were male (91.4%), with a mean age of 75±8.92 years (range 52-94). Four hundred sixty-six patients (87.1%) were treated for AAA, 49 (9.3%) for PAU, and 20 (3.6%) for isolated abdominal aortic dissection. A proximal extension was needed in 48% of the cases. Assisted technical success was achieved in all but one patient (99.8%). At 30 days follow-up, no AAA-related deaths were recorded, and nine patients (1.6%) required reintervention. At a mean follow-up period of 15.22±13.65 (range 1-53) months, data were available for 479 patients (89.5%). Clinical success was achieved in 98.2% (95% confidence interval [CI]: 96.4-99.1) at 3 months, 93.9% (95% CI: 90.1-96.1) at 1 year, and 74.1% (95% CI: 62.8-82.4) at 4 years follow-up. The estimated freedom from all-cause mortality was 97.7%, 93.4%, 81.6%, 77.5%, and 70.9%, and freedom from AAA-related mortality was 100%, 99.6%, 99.6%, 99.6%, and 97.3% at 3, 12, 24, 36, and 48 months, respectively. Twenty reinterventions (3.7%) were required in 19 patients, of which 3 late open conversions (0.6%) were performed, and 2 AAA-related deaths were observed. CONCLUSION: This study demonstrated excellent clinical and technical success rates of EVAR with anatomically fixed endografts, providing valuable insights into real-world clinical outcomes. CLINICAL IMPACT: The AFX2-LIVE study could have a significant impact by providing robust evidence supporting the effectiveness and safety of EVAR using bifurcated endografts with anatomical fixation in real-world clinical practice, ultimately leading to improved outcomes and enhanced patient care in the management of abdominal aortic pathologies.

2.
Eur J Cardiothorac Surg ; 66(4)2024 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-39254638

RESUMEN

OBJECTIVES: To evaluate the results of isolated left subclavian artery in-situ fenestration (ISF) during 'zone 2' thoracic endovascular aortic repair (TEVAR) using a new adjustable needle puncturing device system. METHODS: It is a multicentre, retrospective, physician-initiated cohort study of patients treated from 28 July 2021 to 3 April 2024. Inclusion criteria were isolate left subclavian artery revascularization for elective or urgent/emergent 'zone 2' TEVAR. The primary outcome was technical success and freedom from ISF TEVAR-related reintervention or endoleak. RESULTS: We treated 50 patients: 28 (56.0%) atherosclerotic thoracic aneurysms, 12 (24.0%) type B aortic dissection and 10 (20.0%) penetrating aortic ulcers. Elective intervention was carried out in 46 (92.0%) cases. ISF was successful in all cases, with a procedural primary technical success in 47 (94.0%) cases. The median time of intervention was 184 min (interquartile range 135-220) with a median fenestration time of 20 min (interquartile range 13-35). Operative mortality did not occur. We observed 1 case of spinal cord ischaemia and 2 cases of bilateral posterior non-disabling stroke. Mortality at 30 days occurred in 1 (2.0%) patient (not aorta-related). The median follow-up was 4 months (interquartile range 1-12.25). Bridging stent graft patency was 100% with no ISF-related endoleak. ISF-related reintervention was never required. CONCLUSIONS: ISF TEVAR using the Ankura™-II device with the self-centring adjustable needle system showed high technical success, promising stability and stable aortic-related outcomes. Owing to these results, it represents a safe and effective alternative for standard 'zone 2' TEVAR.


Asunto(s)
Aorta Torácica , Procedimientos Endovasculares , Arteria Subclavia , Humanos , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/instrumentación , Estudios Retrospectivos , Masculino , Femenino , Arteria Subclavia/cirugía , Anciano , Aorta Torácica/cirugía , Persona de Mediana Edad , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/métodos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Resultado del Tratamiento , Disección Aórtica/cirugía , Anciano de 80 o más Años , Reparación Endovascular de Aneurismas
3.
J Endovasc Ther ; : 15266028241270861, 2024 Aug 27.
Artículo en Inglés | MEDLINE | ID: mdl-39188184

RESUMEN

PURPOSE: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. MATERIALS AND METHODS: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. RESULTS: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. CONCLUSION: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. CLINICAL IMPACT: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

4.
J Cardiovasc Surg (Torino) ; 65(1): 49-63, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38037721

RESUMEN

The objective of these Guidelines is to provide recommendations for the classification, indication, treatment and management of patients suffering from aneurysmal pathology of the visceral and renal arteries. The methodology applied was the GRADE-SIGN version, and followed the instructions of the AGREE quality of reporting checklist. Clinical questions, structured according to the PICO (Population, Intervention, Comparator, Outcome) model, were formulated, and systematic literature reviews were carried out according to them. Selected articles were evaluated through specific methodological checklists. Considered Judgments were compiled for each clinical question in which the characteristics of the body of available evidence were evaluated in order to establish recommendations. Overall, 79 clinical practice recommendations were proposed. Indications for treatment and therapeutic options were discussed for each arterial district, as well as follow-up and medical management, in both candidate patients for conservative therapy and patients who underwent treatment. The recommendations provided by these guidelines simplify and improve decision-making processes and diagnostic-therapeutic pathways of patients with visceral and renal arteries aneurysms. Their widespread use is recommended.


Asunto(s)
Aneurisma , Embolización Terapéutica , Humanos , Arteria Renal/diagnóstico por imagen , Radiología Intervencionista , Aneurisma/diagnóstico por imagen , Aneurisma/cirugía , Embolización Terapéutica/efectos adversos , Italia
5.
Ann Vasc Surg ; 101: 120-126, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38110085

RESUMEN

BACKGROUND: Despite the evidence of good performance, carbon dioxide (CO2) routine employment as a contrast agent for endovascular procedures is far from being adopted with its use currently limited to patients with renal impairment and known allergy to iodinated contrast medium (ICM). The purpose of our study is to evaluate the safety and effectiveness of CO2 guided endovascular abdominal aortic aneurysm repair (EVAR) in a standard population and to assess the rationale for a future widespread use. METHODS: We retrospectively collected data of every patient who underwent CO2 guided standard EVAR from September 2020 to May 2021 and compared them with the data of every patient who underwent EVAR using ICM from December 2019 to August 2020 in our unit. The selection of the contrast medium was not based on any preoperative factor as the contrast medium was routinely used in every patient in both periods. The primary end point of the study was the technical success rate. Secondary end points were the early and late complication rates, radiation exposure and renal function impairment. RESULTS: 49 patients underwent ICM guided EVAR and 52 patients underwent CO2 guided EVAR in our unit in the time frames specified above. The technical success rate was 100% in both groups with no accidental coverage of any target vessel. Intraoperative endoleaks were observed in 14% of ICM patients and 25% of CO2 patients. The radiation exposure was higher in the CO2 group if compared to the ICM group (311.48 vs. 159.86 median mGy/cm2 - P < 0.001). The incidence of postoperative acute kidney injury was low and similar in the 2 groups. No significant worsening over time of the renal function has been reported in both groups. CONCLUSIONS: EVAR can be safely performed under CO2 guidance without the integration of any quantity of ICM but with an increase in radiation exposure. The nephroprotective role of CO2 guided EVAR in a standard population is unclear and the same role in renal impaired patients should be validated with further studies on selected populations.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Insuficiencia Renal , Humanos , Medios de Contraste/efectos adversos , Dióxido de Carbono/efectos adversos , Aortografía/efectos adversos , Aortografía/métodos , Estudios Retrospectivos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Implantación de Prótesis Vascular/efectos adversos , Angiografía de Substracción Digital/efectos adversos , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Insuficiencia Renal/etiología , Factores de Riesgo
6.
Cardiovasc Intervent Radiol ; 46(12): 1674-1683, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37978065

RESUMEN

PURPOSE: Comparison of hybrid and total endovascular aortic arch repair at two tertiary vascular surgery centers. MATERIALS AND METHODS: Consecutive patients undergoing hybrid (HG) or total endovascular (TEG) total aortic arch repair for aneurysms or dissections were included (2008-2022). Primary outcome measure was 30-day mortality. Secondary outcomes were major complications, technical success (defined as absence of surgical conversion/mortality, high-flow endoleaks or branch/limb occlusion), clinical success (defined as absence of disabling clinical sequelae), late and aortic-related mortality/reinterventions, freedom from endoleaks, aortic diameter growth > 5 mm, graft migration and supra-aortic trunks (SAT) patency. RESULTS: In total, 30 patients were included, 17 in HG and 13 in TEG. TEG presented shorter intervention time (240.5 vs 341 min, p = 0.01), median ICU stay (1 vs 4.5 days, p < 0.01) and median length of stay (8 vs 17.5 days, p < 0.01). No intraoperative deaths occurred. Technical success was 100%; clinical success was 70.6% in HG and 100% in TEG (p = 0.05). Thirty-day mortality was 13.3%, exclusively in HG (p = 0.11). Nine major complications occurred in 8 patients, 5 in HG and 3 in TEG (p = 0.99), among which five strokes, two in HG and three in TEG (p = 0.62). Late mortality was 38.5%, six patients in HG and four in TEG, p = 0.6. Two late aortic-related deaths occurred in HG (p = 0.9). Two aortic-related reinterventions, no graft migration or SAT occlusion was observed. CONCLUSIONS: Total endovascular repair seems to shorten operative times and provide higher clinical success compared with hybrid solutions, without significant 30-day mortality differences. The most common major complication is stroke.


Asunto(s)
Aneurisma del Arco Aórtico , Aneurisma , Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Accidente Cerebrovascular , Humanos , Prótesis Vascular , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/etiología , Endofuga/cirugía , Implantación de Prótesis Vascular/efectos adversos , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Aneurisma/cirugía , Accidente Cerebrovascular/cirugía , Estudios Retrospectivos , Factores de Riesgo
7.
G Ital Cardiol (Rome) ; 24(5): 344-354, 2023 May.
Artículo en Italiano | MEDLINE | ID: mdl-37102347

RESUMEN

The aim of this paper is to present the diagnostic and therapeutic care pathway on peripheral arterial disease, recently developed in the Piedmont Region, Italy. It proposes a combined approach between the cardiologist and vascular surgeon for optimizing the treatment of patients with peripheral artery disease, which includes the most recently approved antithrombotic and lipid-lowering drugs. The goal is to promote a greater awareness on peripheral vascular disease, in order to implement its treatment patterns and consequently to perform an effective secondary cardiovascular prevention.


Asunto(s)
Fibrinolíticos , Enfermedad Arterial Periférica , Humanos , Fibrinolíticos/uso terapéutico , Vías Clínicas , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/tratamiento farmacológico , Hipolipemiantes/uso terapéutico , Lípidos
8.
Eur J Vasc Endovasc Surg ; 65(6): 811-817, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36871927

RESUMEN

OBJECTIVE: The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. METHODS: Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. RESULTS: In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. CONCLUSION: In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.

9.
J Vasc Surg ; 77(5): 1330-1338.e2, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36621617

RESUMEN

BACKGROUND: Arch pathology represents one of the last frontiers in aortic aneurysm endovascular management. Several companies recently developed dedicated branched and fenestrated endografts specifically designed for the aortic arch, aiming to overcome some of the issues associated with standard thoracic endograft and supra-aortic vessels extra-anatomic debranching. This study aimed to evaluate early outcomes obtained with a custom-made fenestrated endograft approved for thoracic aortic aneurysms exclusion. METHODS: All consecutive patients treated with the Najuta endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) in Italy were enrolled prospectively and included in the study population. Anatomic characteristics and perioperative data were analyzed retrospectively. Study end points were technical success, 30-day clinical success, overall survival, supra-aortic vessel patency, endoleak, and need for reintervention or surgical conversion. RESULTS: Between 2018 and 2022, 76 patients received a Najuta endograft in Italy and were enrolled in the study. The median patient age was 72 years (interquartile range, 69-76 years) and 80.3% were male. Most of the patients received treatment for atherosclerotic aneurysms (80.3%); others were treated for postdissection aneurysms (7.9%), penetrating aortic ulcer (9.2%), or type I endoleak correction after previous thoracic endovascular repair (2.6%). Overall, 161 supra-aortic vessels were preserved through a dedicated fenestration. Technical success was achieved in 74 of 76 procedure (97.4%); both failures were associated with endoleak detection at final angiography (one type I and one type III endoleak). Two distal migrations occurred during the implanting procedure. Clinical success at 30 days was 94.7%. Two early reinterventions were needed within 30 days after index procedure: in one case, an aortic false lumen coils embolization was performed, because distal re-entry caused enlargement of the postdissection thoracic aneurysm. The other procedure consisted of a femoral pseudoaneurysm repair. The median follow-up was 7 months (interquartile range, 3-15 months); no supra-aortic vessel occlusions occurred and no patients needed surgical conversion. CONCLUSIONS: Early results suggest that, in selected patients with aortic arch pathology needing a proximal landing, an endovascular approach with the Najuta system is safe and effective, especially for those at high surgical risk. A strict follow-up with high-quality computed tomography angiography images and eventual evaluation for long-term complications is needed to confirm these initial experience findings.


Asunto(s)
Aneurisma de la Aorta Torácica , Aneurisma de la Aorta , Enfermedades de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Masculino , Anciano , Femenino , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Endofuga/etiología , Endofuga/complicaciones , Estudios Retrospectivos , Factores de Riesgo , Complicaciones Posoperatorias/diagnóstico por imagen , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapia , Resultado del Tratamiento , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/complicaciones , Aneurisma de la Aorta/cirugía , Procedimientos Endovasculares/efectos adversos , Enfermedades de la Aorta/cirugía , Diseño de Prótesis
10.
J Endovasc Ther ; : 15266028221111301, 2022 Jul 19.
Artículo en Inglés | MEDLINE | ID: mdl-35852447

RESUMEN

PURPOSE: Despite encouraging early results, mid- and long-term follow-up of endovascular aneurysm sealing (EVAS) has shown increased rates of failure mainly associated with endoleak detection and progressive bag separation with aneurysm reperfusion. CASE REPORT: We present the first case of a Nellix endograft stent fracture detected in a 91-year-old male patient, presenting with widespread abdominal pain, 7 years after elective treatment of an abdominal aortic aneurysm by EVAS. Considering the sudden and unexpected nature of the event, an in-depth analysis of the possible causes of this structural failure has been performed. CONCLUSION: Material fatigue could be another significant cause of late EVAS failure and should be carefully assessed in addition to endoleak detection during follow-up. CLINICAL IMPACT: The case presented in this article further underlines the importance of a strict long term follow-up protocol in every patients who underwent EVAS.

11.
Clin Case Rep ; 10(2): e05407, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-35145692

RESUMEN

Approximately 25% of patients undergoing transcatheter aortic valve implantation presents significant peripheral arterial disease. The purpose of this case report was to present a feasible approach for transcatheter heart valve in a patient with peripheral arterial disease where the presence of a subclavian stent jutting in the aortic arch made the delivery system passage a challenging procedure.

12.
Catheter Cardiovasc Interv ; 98(1): E115-E121, 2021 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-33893754

RESUMEN

BACKGROUND: While the experience with PCSK9i in patients with coronary artery disease has been wide, and coronary plaque regression has been documented, little is known regarding the role of these drugs on carotid plaque regression. The CARotid plaqUe StabilizatiOn and regression with evolocumab (CARUSO) study is a randomized, single-center, investigator-initiated trial aiming at evaluating carotid plaque morphological stabilization and regression following, respectively, 6 and 12 months of therapy with evolocumab. METHODS: Asymptomatic patients with uni- or bilateral de novo carotid artery stenosis ≥50% and LDL-C values ≥100 mg/dl despite maximum tolerated lipid lowering therapy (LLT) will be randomized to evolocumab 140 mg s.c. every 2 weeks on top of ongoing LLT, or no additional treatment. 100 patients (50 in each arm) will be enrolled. Serial carotid duplex ultra-sonography will be performed to monitor the carotid plaque morphology and stenosis over time. RESULTS: The primary end point of the study is, (a) carotid plaque morphological stabilization at 6 months, defined as defined as the disappearance of ulcerations and fluffy components and the achievement of a regular plaque morphology with prevalence of fibrous atheroma and/or (b) carotid plaque regression at 12 months, defined as reduction of the entity of the stenosis and/or peak systolic velocity by at least 5%, as compared with baseline. CONCLUSION: The CARUSO trial will test the superiority of evolocumab on top of ongoing LLT versus ongoing LLT alone regarding carotid plaque morphological stabilization and regression. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.


Asunto(s)
Estenosis Carotídea , Placa Aterosclerótica , Anticuerpos Monoclonales Humanizados , Arterias Carótidas , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/tratamiento farmacológico , Humanos , Placa Aterosclerótica/tratamiento farmacológico , Resultado del Tratamiento
13.
J Vasc Surg ; 74(4): 1204-1213, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-33684472

RESUMEN

BACKGROUND: Despite promising early results, midterm failures of the Nellix endovascular aneurysm sealing (EVAS) system (Endologix Inc, Irvine, Calif) have been reported at higher than expected rates. The management of proximal endoleaks and migration differs from those after conventional endovascular aortic aneurysm repair (EVAR) owing to the peculiar design of the Nellix device. In the present study, we report a monocentric experience in the management of EVAS complications using various techniques. We also performed a comprehensive review of the relevant literature on both open surgical and endovascular management of proximal failure of EVAS from the MEDLINE database. METHODS: We retrospectively analyzed the reinterventions for type Ia endoleak and migration after elective infrarenal EVAS at our institution. We collected preoperative, intraoperative, and follow-up data. Open and endovascular techniques are described. Overall survival, aortic-related mortality, and the technical success rate (rate of exclusion of endoleaks) with endovascular techniques were the primary outcomes. RESULTS: We performed 101 infrarenal elective EVAS procedures from 2013 to 2018. Of the 101 patients, 20 (19.8%) had required reintervention for proximal sealing failure. The indications were type Ia (Is2, Is3) endoleak, migration >5 mm, sac expansion >5 mm, and secondary rupture. Of the 20 patients, 6 (30%) were treated with endovascular techniques-2 with a chimney Nellix-in-Nellix application and 4 with proximal relining with a covered stent. The remaining 14 patients (70%) were treated with late open conversion (OC). The average time from EVAS to reintervention was 36.1 months (range, 3-65 months). Six patients (30%) had undergone OC in an emergent setting because of secondary rupture. The technical success rate for the patients treated with endovascular reinterventions was 100%. The 30-day mortality was 20% (4 of 20), all emergent cases (four of six emergent repairs; 67%). The overall survival for the 20 patients was 75% (n = 15) at a mean follow-up of 15.1 months (range, 2-47 months). One patient had died after 7 months of non-aortic-related causes. CONCLUSIONS: The high reintervention rate of the Nellix graft mandates careful evaluation for its further use with the revised instructions for use, and it should not be used off-label. OC remains the strategy of choice when managing Nellix proximal sealing failures in fit patients. Chimney Nellix-in-Nellix application and transcatheter embolization are feasible alternative techniques. Proximal relining also appears to be an effective alternative to more complex interventions, although it requires further studies for validation.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Remoción de Dispositivos , Endofuga/cirugía , Procedimientos Endovasculares/efectos adversos , Migración de Cuerpo Extraño/cirugía , Falla de Prótesis , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Remoción de Dispositivos/efectos adversos , Remoción de Dispositivos/mortalidad , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/mortalidad , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Femenino , Migración de Cuerpo Extraño/diagnóstico por imagen , Migración de Cuerpo Extraño/etiología , Migración de Cuerpo Extraño/mortalidad , Humanos , Italia , Masculino , Diseño de Prótesis , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
14.
J Vasc Surg ; 73(6): 1958-1965.e1, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33278539

RESUMEN

BACKGROUND: Endovascular aneurysm sealing (EVAS) is an innovative alternative to conventional endovascular aneurysm repair (EVAR). EVAS relies on sac anchoring without proximal fixation to achieve sealing and should have allowed for the treatment of a broader range of anatomic features compared with standard EVAR. Despite the encouraging early reports, the mid- and long-term follow-up data have shown increased rates of failure. To address the issue, the manufacturer introduced revised instructions for use (IFU) in 2016. The present study reports the outcomes of this system after a median follow-up of 45 months. METHODS: Data for all patients electively treated with EVAS at our institution were retrospectively collected. The patients were retrospectively reclassified according to the 2016 revised IFU of the device. All patients in the present series had undergone EVAS for the treatment of infrarenal abdominal aortic aneurysms (AAAs). The primary end point was therapeutic failure: graft migration >5 mm, sac expansion >5 mm, type IA endoleak (Is2 and Is3 using the Van den Ham classification), type Ib endoleak, and secondary rupture. The overall mortality, aortic-related mortality, and reintervention rates were also analyzed. RESULTS: A total of 101 patients had undergone elective treatment by EVAS from 2013 to 2018 for infrarenal AAAs. The median follow-up was 3.75 years. Therapeutic failure was observed in 31 of the 101 patients (30.7%), with no significant difference between the in-IFU and off-IFU 2016 subgroups. Failure occurred at a median interval of 34 months from the index procedure. Of the 101 patients, 6.9% had presented with secondary rupture. Freedom from aneurysm-related mortality was 96.9% at 1 and 2 years and 89.9% at 5 years. Freedom from reintervention decreased over time: 94.7% at 1 year, 77% at 4 years, and 52.1% at 6 years. Of the 101 patients, 14 (13.9%) had undergone emergent or elective graft explantation. CONCLUSIONS: EVAS performed worse than conventional endografts for several critical end points, regardless of any preoperative anatomic parameters. The incidence of therapeutic failures tended to increase over time, especially 4 years after the index procedure.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/etiología , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Endofuga/etiología , Procedimientos Endovasculares/instrumentación , Migración de Cuerpo Extraño/etiología , Falla de Prótesis , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/mortalidad , Rotura de la Aorta/cirugía , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Remoción de Dispositivos , Endofuga/diagnóstico por imagen , Endofuga/mortalidad , Endofuga/cirugía , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Migración de Cuerpo Extraño/diagnóstico por imagen , Migración de Cuerpo Extraño/mortalidad , Migración de Cuerpo Extraño/cirugía , Humanos , Masculino , Supervivencia sin Progresión , Diseño de Prótesis , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Insuficiencia del Tratamiento
15.
Ann Vasc Surg ; 62: 173-182, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31394211

RESUMEN

BACKGROUND: Endovascular aneurysm repair (EVAR) is currently accepted as an alternative to open repair for the treatment of abdominal aortic aneurysm (AAA). Approximately 40-60% of AAA patients are not considered eligible for EVAR due to unfavorable anatomy. There is currently no consensus on the definition of "hostile" aortic neck for EVAR procedure. METHODS: An Expert Panel (EP), made up of 9 Italian vascular surgeons from high-volume centers (>50 EVAR procedures/year), was assembled to share their opinion about the definition of hostile aortic neck anatomy for EVAR procedure. The process included a review of the current literature by the EP, a face-to-face meeting, and an on-line survey completed by the EP prior to and following the face-to-face meeting, using the Delphi method. RESULTS: Of the 66 reviewed studies, only 38 (58%) reported at least 1 aortic neck hostility criterion. Five anatomic parameters were identified, namely, aortic neck length, aortic neck angulation, aortic neck diameter, conical neck, and presence of circumferential calcification. Based on the results of the first survey round, these criteria and related definitions were discussed in depth during the face-to-face meeting. For 3 parameters (aortic neck diameter, aortic neck angulation, conical neck), the agreement among the EP members was already high during the first survey round while for the remaining 2 (aortic neck length, circumferential calcification) it remarkably increased from the first to the second survey round. For each of these criteria, as well as combinations of at least 2 of these criteria, specific threshold values were identified above or below which a standard EVAR approach was not considered ideal by the EP due to high/moderate risk of complications. CONCLUSIONS: EP agreed on the definition of 5 aortic neck hostility criteria, according to which they gave their opinion on the feasibility and risks of a standard EVAR approach. Further agreement will be needed and examined on the best nonstandard EVAR technique which may be offered in the presence of different combinations of hostility criteria.


Asunto(s)
Aorta Abdominal/diagnóstico por imagen , Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Técnicas de Apoyo para la Decisión , Procedimientos Endovasculares , Terminología como Asunto , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Toma de Decisiones Clínicas , Consenso , Técnica Delphi , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Humanos , Selección de Paciente , Valor Predictivo de las Pruebas , Diseño de Prótesis , Medición de Riesgo , Factores de Riesgo
16.
Ann Vasc Surg ; 55: 310.e5-310.e8, 2019 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-30287296

RESUMEN

BACKGROUND: Successful treatment of tandem lesions of carotid arteries may represent a challenging goal for the vascular specialist. In the "endovascular era," a hybrid approach may represent a viable option. CASE REPORT: We describe the case of a 65-year-old patient with severe postcarotid endarterectomy recurrent stenosis of the internal carotid artery (ICA) associated with primitive stenosis of the proximal common carotid artery (CCA) treated with retrograde stenting and carotid bypass using the Gore Hybrid Vascular Graft (GHVG). CONCLUSIONS: We demonstrated the effectiveness of the hybrid technique using GHVG in treating carotid tandem lesions involving CCA and ICA.


Asunto(s)
Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Arteria Carótida Común/cirugía , Arteria Carótida Interna/cirugía , Estenosis Carotídea/cirugía , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Arteria Carótida Común/diagnóstico por imagen , Arteria Carótida Común/fisiopatología , Arteria Carótida Interna/diagnóstico por imagen , Arteria Carótida Interna/fisiopatología , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/fisiopatología , Angiografía por Tomografía Computarizada , Humanos , Masculino , Diseño de Prótesis , Resultado del Tratamiento
17.
Ann Vasc Surg ; 56: 353.e13-353.e17, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30500654

RESUMEN

Atherosclerotic superficial femoral artery (SFA) true aneurysm is rare and often associated with other aortic or peripheral aneurysms, usually discovered when it reaches a considerable diameter or becomes symptomatic. We present the case of a 92-year-old woman admitted in the emergency department with a huge ruptured SFA aneurysm. The patient underwent successful aneurysmectomy, followed by bypass grafting. Degenerative SFA aneurysms differ from other peripheral aneurysms, being usually larger and symptomatic at presentation, occurring in old people, and representing life-threatening situations. The commonest symptom is rupture.


Asunto(s)
Aneurisma Roto/cirugía , Implantación de Prótesis Vascular , Arteria Femoral/cirugía , Anciano de 80 o más Años , Aneurisma Roto/diagnóstico por imagen , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Angiografía por Tomografía Computarizada , Femenino , Arteria Femoral/diagnóstico por imagen , Humanos , Ligadura , Resultado del Tratamiento
18.
EuroIntervention ; 13(14): 1714-1720, 2018 02 20.
Artículo en Inglés | MEDLINE | ID: mdl-28485278

RESUMEN

AIMS: The aim of the present study was to evaluate periprocedural and 30-day outcomes in a prospective series of patients treated with the CGuard Embolic Prevention System (EPS). METHODS AND RESULTS: From April 2015 to June 2016, a physician-initiated prospective multicentre study was performed in 200 consecutive patients admitted for protected carotid artery stenting (CAS) and treated using the CGuard EPS in twelve vascular centres. Outcome measures were: technical success, periprocedural (0-24 hours) and post-procedural (24 hours-30 days) major and minor strokes, death, acute myocardial infarction (AMI), transient ischaemic attack (TIA), and external carotid occlusion. In three centres, consecutive diffusion-weighted magnetic resonance cerebral imaging (DW-MRI) was performed ≤72 hours prior to and within 72 hours after the intervention. A distal embolic protection device was employed in 182 patients (91%). Technical success was 100%. No death, AMI or major stroke occurred periprocedurally. There were two TIAs and five periprocedural minor strokes (2.5%), including one thrombosis solved by surgery. In the remaining patients (199/200; 99.5%) one-month follow-up duplex ultrasound revealed optimal technical results. Post-procedural clinical follow-up was uneventful. No external carotid artery occlusion occurred. New post-procedural DW-MRI lesions were detected in 12 patients out of 61 (19.6%), including bilateral in five (8.2%) and isolated ipsilateral in six (9.8%), whereas one patient (1.6%) had contralateral only lesions. CONCLUSIONS: Multicentre multi-specialty use of the CGuard EPS in routine clinical practice was associated with no major periprocedural neurologic complications and a total elimination of post-procedural neurologic complications by 30 days.


Asunto(s)
Angioplastia/métodos , Arterias Carótidas , Dispositivos de Protección Embólica , Stents , Anciano , Anciano de 80 o más Años , Angioplastia/efectos adversos , Imagen de Difusión por Resonancia Magnética , Embolia/diagnóstico por imagen , Femenino , Humanos , Masculino , Estudios Prospectivos , Stents/efectos adversos , Factores de Tiempo
19.
Ann Vasc Surg ; 44: 422.e1-422.e7, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28483611

RESUMEN

BACKGROUND: Coral reef aorta (CRA) is a rare, potential lethal disease of the visceral aorta as it can cause visceral and renal infarction. Various surgical approaches have been proposed for the CRA treatment. The purpose of this article is to report different extensive extra-anatomic CRA treatment modalities tailored on the patients' clinical and anatomic presentation. METHODS: From April 2006 to October 2012, 4 symptomatic patients with extensive CRA were treated at our department. Extra-anatomic aortic revascularization with selective visceral vessels clamping was performed in all cases. RESULTS: Technical success was 100%. No perioperative death was registered. All patients remained asymptomatic during the follow-up period (62, 49, 25, and 94 months, respectively), with bypasses and target vessels patency. CONCLUSIONS: The extra-anatomic bypass with selective visceral vessels clamping reduces the aortic occlusion time and the risk of organ ischemia. All approaches available should be considered on a case-by-case basis and in high-volume centers.


Asunto(s)
Enfermedades de la Aorta/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Enfermedades de la Aorta/diagnóstico por imagen , Enfermedades de la Aorta/fisiopatología , Aortografía/métodos , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Stents , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular
20.
Ann Vasc Surg ; 44: 416.e1-416.e4, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28483614

RESUMEN

The most frequent complication during carotid artery stenting (CAS) is intraoperative distal embolization. Three categories of embolic protection devices (EPDs) are routinely used through a transfemoral or transcervical approach: distal occlusion devices, distal EPDs with flow preservation using filters, and the proximal occlusive protective systems. We report the case of the internal carotid artery (ICA) plaque rupture during CAS using a proximal EPD (the Mo.Ma system; INVATEC), treated with immediate surgery. The proximal occlusive protective system permitted the common carotid artery and ICA endoclamping for the time necessary to prepare the patient for the carotid endarterectomy. The EPDs should always be chosen considering the patient's and lesion's characteristics. This knowledge allows their use even as "bridge" endovascular devices.


Asunto(s)
Arteria Carótida Interna/cirugía , Estenosis Carotídea/terapia , Conversión a Cirugía Abierta , Dispositivos de Protección Embólica , Endarterectomía Carotidea , Procedimientos Endovasculares/instrumentación , Stents , Anciano de 80 o más Años , Angiografía , Arteria Carótida Interna/diagnóstico por imagen , Arteria Carótida Interna/fisiopatología , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/fisiopatología , Procedimientos Endovasculares/efectos adversos , Humanos , Masculino , Placa Aterosclerótica , Diseño de Prótesis , Rotura Espontánea , Resultado del Tratamiento
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