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1.
Diagnostics (Basel) ; 14(9)2024 Apr 23.
Artículo en Inglés | MEDLINE | ID: mdl-38732277

RESUMEN

BACKGROUND: Accessory renal arteries (ARAs) frequently coexist with abdominal aortic aneurysms (AAA) and can influence treatment. This study aimed to retrospectively analyze the ARA's exclusion effect on patients undergoing standard endovascular aneurysm repair for AAA. METHODS: The study focused on medium- and long-term outcomes, including type II endoleak, aneurysmal sac changes, mortality, reoperation rates, renal function, and infarction post-operatively. RESULTS: 76 patients treated with EVAR for AAA were included. One hundred and two ARAs were identified: 69 originated from the neck, 30 from the sac, and 3 from the iliac arteries. The ARA treatment was embolization in 15 patients and coverage in 72. Technical success was 100%. One-month post-operative computed tomography angiography (CTA) revealed that 76 ARAs (74.51%) were excluded. Thirty-day complications included renal deterioration in 7 patients (9.21%) and a blood pressure increase in 15 (19.73%). During follow-up, 16 patients (21.05%) died, with three aneurysm-related deaths (3.94%). ARA-related type II endoleak (T2EL) was significantly associated with the ARA's origin in the aneurysmatic sac. Despite reinterventions were not significantly linked to any factor, post-operative renal infarction was correlated with an ARA diameter greater than 3 mm and ARA embolization. CONCLUSION: ARAs can influence EVAR outcomes, with anatomical and procedural factors associated with T2EL and renal infarction. Further studies are needed to optimize the management of ARAs during EVAR.

2.
Artículo en Inglés | MEDLINE | ID: mdl-38636923

RESUMEN

OBJECTIVE: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices. METHODS: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as one year freedom from target vessel instability and main endograft instability. RESULTS: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter renal artery bridging lengths (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, the mortality rate was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At one year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46), respectively. CONCLUSION: Both off the shelf devices provided excellent early and one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

3.
4.
Diagnostics (Basel) ; 14(2)2024 Jan 18.
Artículo en Inglés | MEDLINE | ID: mdl-38248081

RESUMEN

In the context of the COVID-19 pandemic, the global healthcare landscape has undergone significant transformations, particularly impacting the management of complex medical conditions such as aortic aneurysms. This study focuses on a 76-year-old female patient with a history of extensive cardiovascular surgeries, including aortic valve replacement, Bentall operation, and Frozen Elephant Trunk procedure, who presented with a type II thoracoabdominal aortic aneurysm post-COVID-19 recovery. A comprehensive frailty assessment using the Modified Frailty Index and a two-phase endovascular approach for aneurysm treatment, considering the patient's frailty and complex medical history was performed. Upon successful aneurysm management, the patient's postoperative course was complicated by COVID-19 reinfection and Enterococcus faecalis superinfection, highlighting the increased risk of bacterial superinfections and the challenges posed by antimicrobial resistance in COVID-19 patients. The study underscores the necessity of vigilant postoperative surveillance and a multidisciplinary approach in managing such complex cases, highlighting the importance of personalized care strategies, integrating cardiovascular and infectious disease management, and adapting healthcare practices to the unique challenges of the pandemic. This case contributes to the evolution of knowledge on managing aortic aneurysms in the COVID-19 era, advocating for patient-centric treatment approaches and continuous research into long-term patient outcomes.

5.
Diagnostics (Basel) ; 13(23)2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-38066822

RESUMEN

(1) Background: Spontaneous isolated intramural hematoma of the superior mesenteric artery (SIHSMA) is a rare entity often considered as a subset of spontaneous isolated dissection of the superior mesenteric artery (SIDSMA). It is characterized by a completely thrombosed false lumen with or without an ulcer-like projection with computed tomography (CT) imaging. The recent literature describes few reports with a relatively short-term follow-up. The natural course, prognosis, and treatment options for SIHSMA still lack consensus. We present two cases of acute abdominal pain in a young man due to IMH of the superior mesenteric artery with an extensive literature review. (2) Case report: A 46-year-old male patient was submitted to an urgent CTA for acute abdominal pain, showing the presence of an isolated dissection of the superior mesenteric artery, determining significant stenosis of the vessel with collateral vessel patency. The patient referred to a recent COVID-19 infection, whose course was paucisymptomatic. He was conservatively treated with antiplatelet therapy and corticosteroid treatments, and, after a few days, the symptomatology completely regressed; also, the 2-month-control CTA showed complete IMH regression and the absence of any signs of residual stenosis. The second patient was a 61-year-old male patient who was submitted to an urgent CTA for acute abdominal pain, showing the presence of an isolated dissection of the superior mesenteric artery, not determining significant vessel stenosis. He was conservatively treated with antiplatelet therapy and corticosteroid treatment, and after a few days, the symptomatology completely regressed and the radiological control showed complete dissection regression. (3) Conclusion: SISHSMA is a rare entity of vascular pathology, and conservative management represents the best medical strategy. We propose corticosteroid treatment as one of the most appropriate tools in the conservative treatment of SISHSMA.

6.
J Endovasc Ther ; : 15266028231202456, 2023 Sep 26.
Artículo en Inglés | MEDLINE | ID: mdl-37750487

RESUMEN

PURPOSE: This article aims at investigating the outcomes of percutaneous access via the first versus third axillary artery (AXA) segments with closure devices during aortic procedures. MATERIALS AND METHODS: All patients receiving percutaneous AXA access closed with Perclose ProGlide device (Abbott, Santa Clara, California) from 2008 to 2021 were included in a retrospective multicenter registry (NCT: 04589962). Efficacy endpoint was the technically successful percutaneous procedure (no open conversion). Safety endpoints were stroke and access complications according to the Valve Academic Research Consortium-3 reporting standards. The first (AXA1) or third (AXA3) axillary puncture sites were compared. RESULTS: A total of 412 percutaneous AXA accesses were included: 172 (42%) in AXA1 and 240 (58%) in AXA3. Left AXA was catheterized in 363 cases (76% of AXA1 vs 97% of AXA3, p<0.001) and 91% of fenestrated/branched endovascular repair (F/BEVAR) procedures were conducted from the left. A ≥12F internal diameter (ID) sheath was used in 49% of procedures. Open conversion rate was 1%, no major vascular complications occurred, and only one major non-vascular complication was recorded. Primary closure failure occurred in 18 AXA1 (11%) and 32 AXA3 accesses (13%), treated by covered (8.3%) or bare-metal (2.7%) stenting. Bailout stent patency was 100% at median follow-up of 12 months, with 6 of 6 stents still patent after >36 months of follow-up. Stroke rate was 4.4%. An introducer sheath >12F was independently associated with both access complications (p<0.001) and stroke (p=0.005), while a right-side access was associated with stroke only (p=0.034). Even after adjustment for covariates, AXA1 versus AXA3 showed an equal success rate (odds ratio [OR]=0.537, 95% confidence interval [CI]=0.011-1.22 for AXA3, p=0.104). The combination of AXA3 and a >10F introducer sheath provided worse outcomes compared with >10F sheaths through AXA1 (OR for success=0.367, 95% CI=0.176-0.767, p=0.008). This was not confirmed for >12F sheaths, associated with similar outcomes (p=0.31 AXA 1 vs AXA 3). CONCLUSION: Major local complications with the percutaneous axillary approach and ≤12F sheaths are infrequent and solvable by complementary endovascular interventions. Stroke risk remains an issue. First and third AXA segments are both amenable for access with good results, but larger sheaths (12F) perform better in AXA1. CLINICAL IMPACT: Percutaneous access with vascular closure devices at the first or third axillary artery (AXA) segments during aortic procedures is burdened by a negligible risk of open conversion. Local complications with the percutaneous axillary approach are infrequent and solvable by complementary endovascular interventions. First and third AXA segments are both amenable to access with excellent results, but larger sheaths (12F) perform better in the wider first AXA segment. In this setting, bailout stenting does not appear to be associated with mid-term stent occlusion.

7.
Diagnostics (Basel) ; 13(4)2023 Feb 09.
Artículo en Inglés | MEDLINE | ID: mdl-36832134

RESUMEN

BACKGROUND: Arterial and venous thrombosis are complications in SARS-CoV-2-infected patients. The microangiopathic thrombosis in affected patients can compromise results in urgent limb revascularizations. Aim of our study is to report on the incidence of symptoms development in patients affected by popliteal artery aneurysm (PAA) and to analyze the effect of COVID-19 infection on outcomes. METHODS: Data on patients surgically treated for PAA from the massive widespread of COVID-19 vaccine (March 2021) to March 2022 were prospectively collected. Factors considered for analysis were: presence of symptoms, aneurysm diameter and length, time from symptom onset and hospital referral, ongoing or recently COVID-19 infection. Outcomes measures were: death, amputation, and neurological deficit. RESULTS: Between March 2021 and March 2022, 35 patients were surgically treated for PAA. Among them 15 referred to our hospital for symptomatic PAA and were urgently treated. Urgent treatments included both endovascular procedures and open surgeries. Nine out of 15 symptomatic patients had an ongoing or recently recovered COVID-19 infection. COVID-19 infection was strongly associated to symptoms development in patients affected by PAA and to surgical failure in those patients (OR 40, 95% CI 2.01-794.31, p = 0.005). CONCLUSION: In our series, presence of COVID-19 infection was strongly associated to ischemic symptoms onset and to complications after urgent treatment in symptomatic patients.

8.
JACC Cardiovasc Interv ; 14(17): 1917-1923, 2021 09 13.
Artículo en Inglés | MEDLINE | ID: mdl-34391704

RESUMEN

OBJECTIVES: The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry. BACKGROUND: DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion. RESULTS: At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence. CONCLUSIONS: This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.


Asunto(s)
Estenosis Carotídea , Arteria Carótida Interna , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/terapia , Humanos , Estudios Prospectivos , Stents , Resultado del Tratamiento
9.
Ann Vasc Surg ; 76: 342-350, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-33951519

RESUMEN

BACKGROUND: Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. MATERIAL AND METHODS: a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex, clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. RESULTS: Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. CONCLUSIONS: Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures' benefit and outcome.


Asunto(s)
Estenosis Carotídea/terapia , Procedimientos Endovasculares/instrumentación , Disparidades en el Estado de Salud , Stents , Anciano , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Ataque Isquémico Transitorio/etiología , Italia , Masculino , Infarto del Miocardio/etiología , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores Sexuales , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del Tratamiento
11.
Ann Vasc Surg ; 74: 183-193, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-33549787

RESUMEN

PURPOSE: to evaluate the impact of bi- and 3-dimensional preoperative aortic morphological features and their immediate postoperative variations on the outcome of abdominal aortic aneurysms (AAA) treated by endovascular exclusion with standard devices (EVAR). MATERIALS AND METHODS: Double centre retrospective analysis of prospectively collected registry data of EVAR patients. For all patients, preoperative and 30-day computed tomographic angiography images (CTA) were reviewed. Preoperative maximum AAA diameter >59 mm and volume >159 cm3, and any 30-day postoperative increasing at CTA, were considered as potentially influencing the outcome. The outcome measures were: primary technical success; 30-day, 1-year, and mean follow-up reintervention, all-cause and AAA-related mortality rates, and also endoleak-related reinterventions. RESULTS: Three hundred and thrity-three patients were enrolled. Mean preoperative and 30-day AAA diameter and volume were 50.4 mm ± 11.8 vs. 49.1 mm ± 12.1, and 112.9 cm3 ± 79.5 vs. 112.1 cm3 ± 80.5, respectively. Primary technical success was achieved in all cases. At 34.9 months follow-up, cumulative reintervention rate was 12.0%, mortality rates 7.2%, without AAA-related deaths. Endoleak-related reintervention rate was 7.5%. At uni- and multi-variate analysis, preoperative AAA diameter >59 mm, and AAA volume >159 cm3 were significantly associated to reintervention (P = 0.012; P = 0.002), and reintervention and death (P = 0.002; P = 0.001) during follow-up. Additionally, any increase in postoperative AAA diameter or volume was significantly associated with reintervention (P = 0.001, P = 0.001) and reintervention and death (P = 0.006, P = 0.001). Endoleak-related reintervention were also significantly associated with all of the analysed morphological parameters (P = 0.019, P = 0.005, P = 0.005, and P = 0.002, respectively). CONCLUSIONS: Patients with larger baseline AAA size and volume as well as unfavourable early remodelling of the sac are associated to worse long-term EVAR outcome.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico , Aneurisma de la Aorta Abdominal/mortalidad , Aortografía , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico por imagen , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Sistema de Registros , Retratamiento , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Ciudad de Roma , Factores de Tiempo , Resultado del Tratamiento
12.
EuroIntervention ; 16(18): e1544-e1550, 2021 04 02.
Artículo en Inglés | MEDLINE | ID: mdl-31793884

RESUMEN

AIMS: The aim of this study was to report the 30-day technical and clinical success with endovascular repair using the ultra-low-profile Ovation stent graft in patients judged to be outside the instructions for use (IFU) for conventional endografts, while amenable to treatment within the IFU for Ovation. METHODS AND RESULTS: One hundred and twenty-two patients (78.65±7.67 years; 111 male) were enrolled. Patients were evaluated as being outside the IFU for standard endografts because of the absence of a suitable proximal aortic neck in 109 cases (89.3%), of inadequate access vessels in 13 (10.7%), or both in 111 (90.9%). Mean aneurysm (abdominal aortic aneurysm [AAA]) diameter was 52.96±10.1 mm; mean aortic neck length was 7.75±6.05 mm. Technical success (98.4%) was achieved in all but two patients due to a type Ia endoleak. At completion angiography, 15 (12.3%) patients presented a type II endoleak. All patients underwent 30-day follow-up. Primary clinical success at one month was 96.8%, assisted clinical success 98.4%. There were no type I endoleaks, while 12 (9.8%) type II endoleaks were still evident, in the absence of sac expansions. Two patients (1.6%) presented an asymptomatic limb occlusion. CONCLUSIONS: Our experience suggests that, in a selected population of patients with challenging anatomy outside the IFU for conventional endografts, endovascular aneurysm repair (EVAR) using the Ovation stent graft can be performed safely with satisfactory immediate outcomes.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aortografía , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Humanos , Masculino , Diseño de Prótesis , Stents , Resultado del Tratamiento
13.
Future Cardiol ; 17(5): 793-804, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-33225733

RESUMEN

The unibody (Powerlink/AFX/AFX2) Endovascular AAA device (Endologix Inc., CA, USA) presents a unique design with its long main body and two innate limbs. The device is designed to be deployed and sits on the native aortoiliac bifurcation and represents the only one-piece bifurcated endograft designed to use anatomical fixation for endograft stabilization. According to published literature, the unibody device seems to represent a valid choice in the treatment of abdominal aortic aneurysms. This particular device would seem to satisfactorily perform even in the treatment of more compressed aneurysms (also in off-label association with parallel grafts) and in occlusive pathologies. Ongoing studies will provide new real-life data in a large and unselected patient population to better understand the device's advantages and limitations.


Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular , Humanos , Diseño de Prótesis , Stents , Resultado del Tratamiento
15.
JACC Cardiovasc Interv ; 13(18): 2170-2177, 2020 09 28.
Artículo en Inglés | MEDLINE | ID: mdl-32861633

RESUMEN

OBJECTIVES: This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. BACKGROUND: When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. RESULTS: Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. CONCLUSIONS: This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.


Asunto(s)
Estenosis Carotídea , Accidente Cerebrovascular , Humanos , Estudios Prospectivos , Stents , Factores de Tiempo , Resultado del Tratamiento
16.
JACC Cardiovasc Interv ; 13(14): 1709-1715, 2020 07 27.
Artículo en Inglés | MEDLINE | ID: mdl-32703595

RESUMEN

OBJECTIVES: This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). BACKGROUND: Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published. METHODS: The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year. RESULTS: Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis. CONCLUSIONS: This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate.


Asunto(s)
Angioplastia/instrumentación , Estenosis Carotídea/terapia , Stents , Anciano , Anciano de 80 o más Años , Angioplastia/efectos adversos , Angioplastia/mortalidad , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/mortalidad , Bases de Datos Factuales , Femenino , Humanos , Masculino , Diseño de Prótesis , Recurrencia , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/etiología , Trombosis/etiología , Factores de Tiempo , Resultado del Tratamiento
18.
JMIR Res Protoc ; 9(4): e16959, 2020 04 06.
Artículo en Inglés | MEDLINE | ID: mdl-32250278

RESUMEN

BACKGROUND: Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. OBJECTIVE: The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. METHODS: All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. RESULTS: The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients' baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. CONCLUSIONS: This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16959.

19.
Ann Vasc Surg ; 67: 274-282, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32209404

RESUMEN

BACKGROUND: The aim of the present study was to evaluate early-, mid-, and long-term outcomes in an unselected population of patients treated for abdominal aortic aneurysms (AAAs) by endovascular aneurysm repair (EVAR) with different commercially available off-the-shelf devices. MATERIALS AND METHODS: A retrospective study was conducted on a prospectively compiled computerized database on patients presenting an infrarenal AAA treated between January 2008 and December 2015 in a high-volume Italian tertiary referral Center. Demographic, clinical, and specific morphological features were considered as potentially influencing the outcomes and the type of the implanted device. Outcome measures were procedure-related reintervention, AAA-related, and all-cause mortality rates at 30-day, 12-month, and long-term follow-up. Reinterventions considered for the analysis were AAA rupture, graft infection, type I or III endoleaks, type II endoleaks with sac enlargement > 5 mm, graft stenosis or occlusions, procedures related to renal or visceral ischemia, and reintervention for access vessel injury. RESULTS: Of 498 EVAR procedures performed for elective infrarenal AAA treatment during the entire study period, 479 patients were enrolled, the mean age was 73.5 ± 7.34 years (range 51-91), and 416 (86.84%) were men. The mean maximum AAA diameter was 52.02 ± 8.04 mm (range 39-90.2), a maximum AAA diameter ≥59 mm was recorded in 107 patients (22.33%), and an aortic neck length was <10 mm in 137 (28.60%). Technical success was achieved in all patients. At a mean follow-up of 52.97 ± 26.16 months (range 1-120), overall reintervention and death rates were 8.14% and 20.04%, respectively, without AAA-related deaths. At univariate analysis, hypertension was the only demographical variable found to be associated with higher risk of reintervention, P = 0.04 (OR: 2.34; CI 95%: 1.00-5.42). Furthermore, male sex (P = 0.02; OR: 2.62; CI 95%: 1.09-6.27) and chronic renal insufficiency (P = 0.003; OR: 2.08; CI 95%: 1.27-3.42) were associated with higher mortality rates. AAA diameter ≥59 mm was statistically associated with a higher rate of both reintervention and mortality: P < 0.001 (OR: 9.05; CI 95%: 4.52-18.11) and <0.001 (4.00; 2.46-6.49), respectively. CONCLUSIONS: Our experience seems to suggest that EVAR could be safely and effectively performed in an unselected patients' population, with encouraging results up to a ten-year follow-up.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Bases de Datos Factuales , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Ciudad de Roma , Stents , Factores de Tiempo , Resultado del Tratamiento
20.
Ann Vasc Surg ; 63: 458.e1-458.e6, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31648033

RESUMEN

The aim of this study is to report the outcome of immediate and direct revascularization by mechanical thrombectomy in acute limb ischemia due to thrombosed popliteal artery aneurysm (PAA). Two patients with acute limb ischemia due to PAA thrombosis were admitted at our hospital, and immediately treated by mechanical thrombectomy (Indigo System). The first patient had a complete recanalization after thrombectomy, while the second one required urokinase infusion (12 hr) due to a suboptimal result. After revascularization, both patients were treated by a polytetrafluoroethylene bypass to definitively exclude PAA. Follow-up showed the patency of the femoropopliteal bypass with good distal outflow. In these 2 reported cases, the Indigo System® has proven to be safe and effective, allowing an immediate limb reperfusion, reducing the necessity for thrombolytic drug infusion.


Asunto(s)
Aneurisma/terapia , Isquemia/terapia , Arteria Poplítea , Trombectomía/instrumentación , Trombosis/terapia , Enfermedad Aguda , Anciano , Aneurisma/diagnóstico por imagen , Aneurisma/fisiopatología , Humanos , Isquemia/diagnóstico por imagen , Isquemia/fisiopatología , Masculino , Persona de Mediana Edad , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Succión/instrumentación , Trombosis/diagnóstico por imagen , Trombosis/fisiopatología , Resultado del Tratamiento , Grado de Desobstrucción Vascular
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