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1.
J Endovasc Ther ; : 15266028241255531, 2024 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-38813950

RESUMO

PURPOSE: The aim of the study is to analyze our single-center experience in endovascular treatment of splenic artery aneurysms (SAAs) with transcatheter coil embolization, comparing long-term outcomes of packing and sandwich techniques. MATERIALS AND METHODS: Between January 2010 and December 2021, 28 patients with certain diagnosis of non-ruptured asymptomatic SAA were treated with 2 different embolization techniques (packing, n=10, and sandwich, n=18). Early outcomes assessed were technical success, overall mortality, mean hospital stay, post-embolization syndrome rate, and freedom from splenectomy rate. Estimated 5-year outcomes in terms of freedom from sac reperfusion, and freedom from reintervention were evaluated and compared between the 2 different embolization techniques. RESULTS: The mean SAA diameter was 2.8±0.8 cm. Overall technical success rate was 100%. Intraoperative and 30-day mortality rates were 0 in both groups. One patient in the sandwich group required a postoperative splenectomy. The mean follow-up period was 58.3±44.5 months. Estimated overall 5-year survival was 86.7%. Five-year freedom from sac reperfusion was 100% in the sandwich group, and 85.7% in the packing group, with no difference between the 2 groups (p=0.131), whereas freedom from reintervention was 100% in the sandwich group, and 75% in the packing group with a statistically significant difference (p=0.049; log-rank=3.750). CONCLUSIONS: Embolization of SAAs seemed to be safe and effective with 100% of technical success rate and good perioperative results. Both sandwich and packing techniques yielded promising results also in the long-term period. CLINICAL IMPACT: Transcatheter coil embolization of splenic artery aneurysms seems to be a safe and effective procedure with a 100% technical success and satisfactory perioperative outcomes. Sandwich and packing techniques offer good results in the long-term period. Freedom from reintervention seems to be optimal and comparable between the 2 techniques.

2.
J Endovasc Ther ; : 15266028241275827, 2024 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-39240031

RESUMO

PURPOSE: The aim of this project is to explore practice patterns of experienced vascular specialists involved in the treatment of patients with arterial femoro-popliteal in-stent occlusion (ISO) and to understand key concepts and shared thoughts, throughout an international cross-sectional survey. MATERIALS AND METHODS: The web-based survey was in English and included 31 questions. One-hundred experts were invited by email to fill in the survey anonymously on Google Forms using a dedicated link. Reminders were sent after the first 2 weeks. In addition to reporting of pooled responses, subanalyses of answers were also performed, according to country of origin (European vs non-European), years of experience (≤20 years vs >20 years), and type of institution (Academic/University vs Non-academic/Private). RESULTS: A total of 77 physicians from 22 countries completed the survey. Most responders were males (70/77, 91%). Most of the participants were vascular surgeons (58/77, 75%). Endovascular therapy was the preferred option in patients presenting with either acute limb ischemia, disabling intermittent claudication, or chronic limb-threatening ischemia. Atherectomy/thrombectomy+Drug-Coated Balloon (DCB) was the preferred endovascular modality (32/77, 42%). No differences between country of origin, years of experience, and type of institution of the participants were found. CONCLUSIONS: The international SUrvey oN TReatment Of Occluded Femoro-Popliteal Stent (SUNROOF) survey has suggested that endovascular therapy is the preferred method for the treatment of femoro-popliteal ISO. This survey could represent a good starting point for future research on comparison between open and endovascular approach and different devices, which currently lacks good-level scientific evidence and appropriate guidelines. CLINICAL IMPACT: The international SUNROOF survey included 31 questions. It was performed by 77 vascular physicians from 22 countries. More than a half of respondents considered an endovascular approach as the preferred treatment modality in acute limb ischemia, disabling intermittent claudication, or chronic limb-threatening ischemia. Most responders agreed they would intensify the follow-up protocol and anti-thrombotic medications regimen after a first in-stent occlusion episode. This survey could represent a good starting point for future research on comparison between open and endovascular approach and different devices, which currently lacks of good level scientific evidence and appropriate guidelines.

3.
J Endovasc Ther ; : 15266028241275804, 2024 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-39287104

RESUMO

PURPOSE: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device. MATERIALS AND METHODS: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies. RESULTS: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide. CONCLUSION: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide. CLINICAL IMPACT: Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group.

4.
Artigo em Inglês | MEDLINE | ID: mdl-39154953

RESUMO

OBJECTIVE: The aim of this study was compare elective surgical repair of popliteal artery aneurysms (PAAs) via a posterior approach vs. endovascular exclusion, analysing early and five year outcomes in a multicentre retrospective study. METHODS: Between January 2010 and December 2023, a retrospectively maintained dataset of all consecutive asymptomatic PAAs that underwent open repair with posterior approach or endovascular repair in 37 centres was investigated. An aneurysm length of ≤ 60 mm was considered the only inclusion criterion. A total of 605 patients were included; 440 PAAs (72.7%) were treated via a posterior approach (open group) and the remaining 165 PAAs (27.3%) were treated using covered stents (endo group). Continuous data were expressed as median with interquartile range. Thirty day outcomes were assessed and compared. At follow up, primary outcomes were freedom from re-intervention, secondary patency, and amputation free survival. Secondary outcomes were survival and primary patency. Estimated five year outcomes were compared using log rank test. RESULTS: At 30 days, no differences were found in major morbidity, mortality, graft occlusion, or re-interventions. Three patients (0.7%) in the open group experienced nerve injury. The overall median duration of follow up was 32.1 months. At five year follow up, freedom from re-intervention was higher in the open group (82.2% vs. 68.4%; p = .021). No differences were observed in secondary patency (open group 90.7% vs. endo group 85.2%; p = .25) or amputation free survival (open group 99.0% vs. endo group 98.4%; p = .73). A posterior approach was associated with better survival outcomes (84.4% vs. 79.4%; p = .050), and primary patency (79.8% vs. 63.8%; p = .012). CONCLUSION: Early and long term outcomes following elective repair of PAAs measuring ≤ 60 mm via a posterior approach or endovascular exclusion seem comparable. Nerve injury might be a rare but potential complication for those undergoing open surgery. Endovascular repair is associated with more re-interventions.

5.
Vascular ; : 17085381241273221, 2024 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-39135264

RESUMO

OBJECTIVES: The aim of this cross-sectional survey was to gather attitudes and practices of physicians from different countries regarding the implementation of contrast-enhanced ULTRAsound (CEUS) for vascular diseases in clinical practice as well as in academic research. METHODS: A web-based survey was developed in English, including 35 questions. Two-hundred sixty physicians were invited by email to fill in the survey anonymously on Google Forms using a dedicated link. The survey started on 25th February 2024 and was closed on 13th March 2024 (17 days). A reminder was sent after the first 10 days. In addition to descriptive statistics, sub-analyses of answers according to country of origin (Italy vs other States), years of experience (≤20 years vs > 20 years), and type of institution (Academic/University vs Non-Academic/Private) were also established a priori. RESULTS: A total of 121 practitioners from 20 countries completed our survey (response rate 121/260, 46%). Most responders were males (95/121, 78.5%). Most participants were vascular surgeons (118/121, 97.5%). CEUS was available in 87/121, 70.2% of the centers involved, even though a standardized protocol was present in 54/121, and 44% of surveyed institutions. Italian institutions presented greater CEUS availability (62/72, 86.1% vs 25/49, 51.0%; p = .001) and higher presence of standardized protocols (38/72, 52.8% vs 16/49, 32.6%; p = .022) than foreign institutions. The diagnostic tool was thought to be more useful for carotid artery stenosis in the postoperative phase, while for abdominal aortic aneurysms (AAAs) in the preoperative phase. For diagnosis and/or preoperative management of carotid stenosis 53/121, 44% of physicians believed that CEUS should be performed only in selected cases, while for AAA 42/121, 35% of them believed that it could be useful only for scientific purposes. Similarly, 99/121, 82% of participants answered that CEUS was usually prescribed in 0%-20% of the cases during the preoperative diagnostic pathway of patients with peripheral arterial disease. No differences between country of origin, years of experience, and type of institution were found for the reported items. There was also 106/121, 88% of respondents agreed upon the need for better integration of CEUS in current guidelines and 114/121, 94% of them upon the need for further studies. CONCLUSIONS: This ULTRA-VASC survey has demonstrated that CEUS is still rarely used in current practice for many vascular diseases despite the availability of this tool in most centers Future studies are needed, as well as enhanced guidance on the proper implementation of CEUS from guidelines.

6.
Vascular ; : 17085381241258556, 2024 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-38817014

RESUMO

OBJECTIVES: The aim of this study was to evaluate the effectiveness of protein-based tissue adhesive (Bioglue®) in reducing time to haemostasis in patients undergoing peripheral vascular surgery. METHODS: From January to December 2021, 100 consecutive patients from 4 centres have been treated with open peripheral vascular surgery including upper and lower limb interventions. Patients have been allocated in each centre into control with no use of Bioglue® (Group no-Bio, 50 patients) or use of Bioglue® (Group Bio, 50 patients) by a block randomization method 10:10 until the required sample size was reached. Perioperative parameters including time to haemostasis, number of adjunctive stitches, and in-hospital bleeding have been analysed and compared in the two groups by means of mean independent-samples tT -test and Gehan-Breslow-Wilcoxon test. RESULTS: Both groups were homogeneous in terms of demographic data, preoperative risk factors, and preoperative medical therapy except for a higher percentage of active smokers in Group Bio (52% vs. 24%, p = 0.004). Femoral endarterectomy was most common in Group Bio (44% vs. 24%, p = 0.03), whilst the percentage of lower limb vein bypasses was higher in Group no-Bio (50% vs. 36%, p = 0.03). Bovine pericardium was the preferred material in Group Bio (20 cases, 40%), whilst autologous vein is mostly used in Group no-Bio (26 cases, 52%) (p = 0.01). Time to haemostasis was faster in Group Bio (4.4 vs. 9.6 minutes, p < 0.001). The need for adjunctive stitches was higher in Group no-Bio (8 cases, 16%, Group Bio vs. 25 cases, 50%, Group no-Bio; p < 0.001). The overall rate of in-hospital bleeding, including those requiring reintervention, was not different between the two groups (9 cases, 18%, Group Bio vs. 7 cases, 14%, Group no-Bio; p = 0.39). CONCLUSIONS: The protein-based tissue adhesive Bioglue® reduced time to haemostasis and need for adjunctive stitches in peripheral vascular surgery. However, it did not affect the overall rate of perioperative bleedings. Further studies with larger sample sizes are needed to validate these outcomes.

7.
J Vasc Surg ; 77(1): 231-240.e4, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35934215

RESUMO

BACKGROUND: The mid-term results after treatment of isolated popliteal lesions have been limited. The aim of the present study was to report the mid-term outcomes after endovascular treatment of isolated atherosclerotic popliteal artery lesions. METHODS: A multicenter (15 hospitals in five countries) retrospective cohort study was performed. Between June 2016 and June 2021, 651 consecutive patients who had been treated for isolated popliteal lesions using endovascular methods exclusively were included in the present study. Six techniques were identified, including plain balloon angioplasty (PTA; n = 286; 43.9%), drug-coated balloon angioplasty (n = 98; 15.1%), stenting with low-chronic outward force (COF) stents (n = 84; 12.9%), stenting with high-COF stents (n = 76; 11.7%), atherectomy alone (n = 17; 2.6%), and directional atherectomy with drug-coated balloons (n = 90; 13.8%). The primary outcomes measures were primary and secondary patency and freedom from clinically driven target lesion revascularization (F-CDTLR). RESULTS: The mean patient age was 74.5 years. Most of the patients (n = 409; 62.9%) had had chronic limb-threatening ischemia. Popliteal occlusion was found in 400 cases (61.4%). High-grade calcification was present in 36.7% of cases. Immediate technical success was 94.8%. The median follow-up was 26 months (range, 6-42 months). The actuarial rate for all patients at 26 months (per outcome measure) was as follows: primary patency, 73.9%; secondary patency, 88%; and F-CDTLR, 76.5%. When comparing PTA vs all other treatments in an adjusted regression analysis, the F-CDTLR was 75.2% for PTA vs 76.5% for all other treatment (hazard ratio, 1.06; 95% confidence interval, 0.75-1.48; P = .46, adjusted regression). The difference in secondary patency also was not statistically significant (85.7% for PTA vs 88%; P = .20). Adjusted Kaplan-Meier analysis revealed that the estimated primary patency was inferior for PTA in pairwise comparisons vs other treatments (P < .001 vs atherectomy; P = .002 vs directional atherectomy with drug-coated balloons; and P = .002 vs low-COF stenting). CONCLUSIONS: The results from our study have shown that endovascular treatment of isolated popliteal lesions is safe and associated with acceptable patency and F-CDTLR in the mid-term.


Assuntos
Angioplastia com Balão , Aterosclerose , Doença Arterial Periférica , Humanos , Idoso , Artéria Poplítea/diagnóstico por imagem , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Estudos Retrospectivos , Resultado do Tratamento , Angioplastia com Balão/efeitos adversos , Sistema de Registros , Grau de Desobstrução Vascular , Artéria Femoral , Materiais Revestidos Biocompatíveis
8.
J Vasc Surg ; 78(5): 1270-1277, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37532160

RESUMO

OBJECTIVE: The aim of the study was to compare the early and medium-term outcomes of bypass vs endovascular treatment of occluded femoro-popliteal stents in patients with chronic limb-threatening ischemia (the OUT-STEPP multicentric registry). METHODS: Between January 2016 and December 2021, 317 patients in 14 centers underwent treatment for a symptomatic occlusion of femoro-popliteal stent/stents. One hundred sixty-one patients were included into the present study: 46 (28.6%) underwent open bypass surgery (Group OPEN), and 115 (71.4%) underwent endovascular revascularization (Group ENDO). Early (30 days) results were assessed and compared between the two groups. Estimated 5-year outcomes were evaluated and compared with the log rank test. RESULTS: At 30 days, no differences were found in terms of major adverse cardiovascular events, acute kidney injury, reinterventions, major amputation, and all-cause mortality between the two groups. The need for blood transfusions was higher for patients in Group OPEN (17; 36.9% vs 13; 11.3%; P < .001). The mean length of intensive care unit stay and the mean hospital stay were higher for patients in Group OPEN ([0.3 ± 0.9 vs 0 days; P < .001] and [9.7 ± 5.8 vs 3.3 ± 1.4 days; P < .001], respectively). The overall median duration of follow-up was 33.1 months (interquartile range, 14-49.5 months). At 5 years, there were no differences between the two groups in terms of survival (68.7% Group OPEN vs 68.8% Group ENDO; P = .27; log-rank, 1.21), primary patency (56.3% Group OPEN vs 67.8% Group ENDO; P = .39; log-rank, 0.75), secondary patency (59.1% Group OPEN vs 77.8% Group ENDO; P = .24; log-rank, 1.40), absence of target lesion restenosis (56.8% Group OPEN vs 62.7% Group ENDO; P = .42; log-rank, 0.65), and limb salvage (77.2% Group OPEN vs 90.4% Group ENDO; P = .17; log-rank, 1.87). CONCLUSIONS: Both bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in patients with chronic limb-threatening ischemia. Open surgery was associated with longer stay in hospital and increased use of blood transfusions. At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.

9.
J Endovasc Ther ; : 15266028231197151, 2023 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-37646124

RESUMO

PURPOSE: Zenith Alpha Abdominal (Cook Medical, Bloomington, IN, USA) is one of the new-generation low-profile stent-grafts with demonstrated satisfactory early and midterm clinical outcomes for endovascular treatment of abdominal aortic aneurysms (AAAs). The aim was to evaluate early and midterm results of this device in the framework of a multicenter regional retrospective registry, with the analysis of morphological factors affecting outcomes, including different limb configurations. MATERIALS AND METHODS: Between January 2016 and November 2021, 202 patients with AAA underwent elective endovascular aneurysm repair (EVAR) with implantation of a Zenith Alpha Abdominal in 7 centers. Early (30 day) outcomes in terms of technical and clinical success were assessed. Estimated 5 year outcomes were evaluated in terms of survival, freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and graft infection evaluation by life-table analysis (Kaplan-Meier test). A comparative analysis between different limb configurations (Zenith Spiral Z AAA iliac legs, codes ZISL vs ZSLE) was performed in terms of limb graft occlusion. RESULTS: The 30 day technical and clinical success rates were 97.5% and 99.5%, respectively. Median follow-up period was 25.5 months (interquartile range [IQR]: 12-43.25). The 5 year survival rate was 73.6%. The estimated 5 year outcomes in terms of freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and freedom from graft infection were 88.6% (95% CI [confidence interval]: 83.4%-93.1%), 95.8% (95% CI: 92.7%-97.1%), 93.6% (95% CI: 90.2%-96.8%), 87% (95% CI: 83.3%-91.6%), and 97.7% (95% CI: 95.1%-98.9%), respectively. About limb configuration, no differences were found in terms of 5 year freedom from limb graft occlusion (ZSLE 93.4% [95% CI: 89.8%-95.5%] vs ZISL 94.3% [95% CI: 90.1%-95.9%], p=0.342; log-rank 0.903). CONCLUSION: Zenith Alpha Abdominal in elective EVAR offered satisfactory early and 5 year outcomes with low complication rates. Limb graft occlusion continued to be an issue. Limb configuration did not affect outcomes. CLINICAL IMPACT: The authors describe satisfactory early and 5 year outcomes of Zenith Alpha Abdominal in elective endovascular aortic repair in the framework of a multicenter regional retrospective registry. At 5 years freedom from type I endoleak was 88.6%, and rate of endograft infections and conversions to open repair were very low. in the present study. Hot topic about about Zenith stent-graft still remains the limb graft occlusion with a 30-day overall rate of 2%, and estimated 5-year freedom from limb graft occlusion of 93.6%. Limb graft configuration did not affect limb graft occlusion rate. A standardized protocol including iliac stenting should be adopted to reduce kimb graft occlusion.

10.
J Endovasc Ther ; 30(6): 817-821, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-35698790

RESUMO

The absence of an adequate ileo-femoral access is usually considered an absolute contraindication to fenestrated and branched aortic repairs. Alternative routes and dedicated stent-graft designs have been advocated. Hereby, we describe the case of a 73-year-old man with a recurrent type IV thoracoabdominal aortic aneurysm and complete thrombotic pararenal aortic occlusion treated successfully with a tri-branch custom-made endograft deployed via a transaxillary access.


Assuntos
Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Arteriopatias Oclusivas , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Humanos , Idoso , Prótese Vascular , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Abdominal/cirurgia , Fatores de Risco , Resultado do Tratamento , Stents , Desenho de Prótese , Arteriopatias Oclusivas/cirurgia
11.
J Vasc Surg ; 76(3): 797-805, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35561942

RESUMO

BACKGROUND: The aim of this study was to compare the 2-year outcomes of de novo versus postendovascular lesion treatment of femoropopliteal occlusions included in a national, multicenter, observational, prospective registry based on the treatment of critical Limb-threatening IschaeMia with infragenicular Bypass adopting in situ SAphenous VEin technique (LIMBSAVE) registry. METHODS: From January 2018 to December 2019, 541 patients from 43 centers have been enrolled in the LIMBSAVE registry. Of these patients, 460 were included in the present study: 341 (74.1%) with de novo lesions (DN group) and 119 (25.9%) with postendovascular treatment lesions (PE group). Initial outcome measures were assessed at 30 days after treatment. Furthermore, at the 2-year follow-up, the estimated outcomes of primary patency, primary-assisted patency, secondary patency, and limb salvage were analyzed with Kaplan-Meier curves and compared between groups with the log-rank test. RESULTS: Both groups were homogeneous in terms of demographic data, preoperative risk factors, and clinical presentation. However, compared with DN group, more patients in PE group had a great saphenous vein diameter of less than 3 mm (11.1% vs 21%; P = .007). Intraoperatively, both groups showed similar distal anastomosis sites: below-the-knee popliteal artery (63% DN group, 66.4% PE group) and tibial vessel (37% DN group, 33.6% PE group) (P = .3). The overall mean duration of follow-up was 11.6 months (range, 1-24 months). At the 2-year follow-up, there were no differences between the two groups in terms of primary patency (66.3% DN group vs 74.1% PE group; P = .9), primary-assisted patency (78.2% DN group vs 79.5% PE group; P = .2), secondary patency (85.1% DN group vs 91.4% PE group; P = .2), and limb salvage (95.2% DN group vs 95.1% PE group; P = .9). CONCLUSIONS: The LIMBSAVE registry did not show a worsening of overall patency and limb salvages rates at the 2-year follow-up in patients undergoing in situ saphenous bypass after a failed endovascular approach for long femoropopliteal occlusive disease. This finding is in contrast with what has been published in literature.


Assuntos
Prótese Vascular , Artéria Femoral , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Humanos , Isquemia/diagnóstico por imagem , Isquemia/cirurgia , Salvamento de Membro/métodos , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/cirurgia , Desenho de Prótese , Estudos Retrospectivos , Veia Safena/diagnóstico por imagem , Veia Safena/cirurgia , Resultado do Tratamento , Grau de Desobstrução Vascular
12.
Eur J Vasc Endovasc Surg ; 64(4): 350-358, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35714849

RESUMO

OBJECTIVE: The aim was to demonstrate contemporary outcomes of in situ saphenous vein bypass using a valvulotome. METHODS: Analysis of two year outcomes of a multicentre registry based on the treatment of critical Limb Ischaemia with infragenicular Bypass adopting in situ SAphenous VEin technique (LIMBSAVE). Between January 2018 and December 2019, 541 patients in 43 centres were enrolled. In all patients an innovative valvulotome was used. Early outcomes were assessed. Two year outcomes according to Kaplan-Meier curves in terms of patency and limb salvage were evaluated. Associations between patient and procedure variables were analysed with univariable and multivariable analyses. RESULTS: In all cases, a valvulotome was able to lyse the valves. Vein injury due to the in situ technique was 3.5%. Thirty day mortality and major amputation rates were 3% and 0.9%, respectively. Mean follow up was 12.1 months. Two year estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 69.1%, 81.4%, 86.5%, and 94.5%, respectively. Multivariable analysis showed an association between pre-operative vein diameter < 3 mm and lower primary patency (hazard ration [HR] 14.3, p < .001), primary assisted patency (HR 9.4, p = .002), secondary patency (HR 7.2, p = .007), and limb salvage (HR 7.8, p = .005) rates. Distal anastomosis to a tibial or foot vessel was also associated with lower primary patency (HR 4.8, p = .033), and primary assisted patency (HR 6, p = .011) rates. Use of a suprafascial tributary collateral as a graft was associated with lower primary patency (HR 6.7, p = .013), and primary assisted patency (HR 4.2, p = .042) rates. CONCLUSION: Vein diameter < 3 mm, distal anastomosis on a tibial or foot vessel, and use of a suprafascial tributary collateral as a graft were significantly associated with loss of patency and limb loss during follow up.


Assuntos
Isquemia Crônica Crítica de Membro , Veia Safena , Humanos , Veia Safena/cirurgia , Grau de Desobstrução Vascular , Isquemia/diagnóstico por imagem , Isquemia/etiologia , Isquemia/cirurgia , Estudos Retrospectivos , Salvamento de Membro/métodos , Sistema de Registros , Resultado do Tratamento , Fatores de Risco
13.
Surg Endosc ; 36(9): 6473-6479, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35020053

RESUMO

BACKGROUND: Artificial intelligence (AI) has the potential to enhance patient safety in surgery, and all its aspects, including education and training, will derive considerable benefit from AI. In the present study, deep-learning models were used to predict the rates of proficiency acquisition in robot-assisted surgery (RAS), thereby providing surgical programs directors information on the levels of the innate ability of trainees to facilitate the implementation of flexible personalized training. METHODS: 176 medical students, without prior experience with surgical simulators, were trained to reach proficiency in five tasks on a virtual simulator for RAS. Ensemble deep neural networks (DNN) models were developed and compared with other ensemble AI algorithms, i.e., random forests and gradient boosted regression trees (GBRT). RESULTS: DNN models achieved a higher accuracy than random forests and GBRT in predicting time to proficiency, 0.84 vs. 0.70 and 0.77, respectively (Peg board 2), 0.83 vs. 0.79 and 0.78 (Ring walk 2), 0.81 vs 0.81 and 0.80 (Match board 1), 0.79 vs. 0.75 and 0.71 (Ring and rail 2), and 0.87 vs. 0.86 and 0.84 (Thread the rings 2). Ensemble DNN models outperformed random forests and GBRT in predicting number of attempts to proficiency, with an accuracy of 0.87 vs. 0.86 and 0.83, respectively (Peg board 2), 0.89 vs. 0.88 and 0.89 (Ring walk 2), 0.91 vs. 0.89 and 0.89 (Match board 1), 0.89 vs. 0.87 and 0.83 (Ring and rail 2), and 0.96 vs. 0.94 and 0.94 (Thread the rings 2). CONCLUSIONS: Ensemble DNN models can identify at an early stage the acquisition rates of surgical technical proficiency of trainees and identify those struggling to reach the required expected proficiency level.


Assuntos
Aprendizado Profundo , Procedimentos Cirúrgicos Robóticos , Inteligência Artificial , Competência Clínica , Simulação por Computador , Humanos , Procedimentos Cirúrgicos Robóticos/educação
14.
Vascular ; 30(1): 63-71, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33691547

RESUMO

OBJECTIVES: Revascularization according to the angiosome concept is of proven importance for limb salvage in chronic limb threatening ischaemia but it is not always practicable. Bifurcated bypasses could be considered as an option when an endovascular approach is not feasible or has already failed and a single bypass would not allow direct revascularization of the ischaemic area. Bifurcated bypasses are characterized by landing on two different arteries, the main artery (in direct continuity with the foot vessels) and the secondary one (perfusing the angiosome district). The aim of this study is to evaluate the safety and effectiveness of bifurcated bypass in chronic limb threatening ischaemia. METHODS: Thirty-five patients were consecutively treated with a bifurcated bypass for chronic limb threatening ischaemia from January 2014 to December 2019 in a single vascular surgery centre. Data from clinical records and operative registers were collected prospectively in an electronic database and retrospectively analysed. Primary and primary assisted bypass patency, amputation-free survival, morbidity and mortality rates at 12 and 24 months were analysed. RESULTS: Mean follow-up period was 25.1 months (range 2-72 months). Thirty-six bifurcated bypasses were performed on 35 patients (age 75.3 ± 7.2 years; 69.4% were male). According to Wound, Ischemia, foot Infection classification 22.2% belonged to stage 3 and 77.8% to stage 4 and the mean Rutherford's class was 5.1 ± 0.7. Immediate technical success was 100%. Early mortality and morbidity rates were respectively 5.5%, and 33.3%; foot surgery was performed in 50% of cases with wound healing in all patients. Primary patency and primary assisted bypass patency were 96.7% and 100% at 6 months; 85.2% and 92% at 12 months, 59.9% and 73.4% at 24 months, respectively. Amputation-free survival at 12 and 24 months was, respectively, 95.6% and 78.8%. Overall survival rates at 12 and 24 months were respectively 94.4% and 91.6%. CONCLUSIONS: Bifurcates bypass can provide good results in patients with chronic limb threatening ischaemia without endovascular option, especially in diabetic ones. Bifurcated bypass is a complex surgical solution, both to be planned and performed, and it is quite invasive for frail patients that should be accurately selected.


Assuntos
Isquemia Crônica Crítica de Membro , Doença Arterial Periférica , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Humanos , Isquemia/diagnóstico por imagem , Isquemia/cirurgia , Salvamento de Membro/métodos , Masculino , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/cirurgia , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Grau de Desobstrução Vascular
15.
J Vasc Surg ; 71(3): 842-853, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31471234

RESUMO

OBJECTIVE: Plaque stability is of utmost importance for stroke prevention in the perioperative period (within 24 hours) following carotid artery stenting (CAS). Although carotid plaque is entrapped between stent struts after stent deployment, postdilation can cause a scissoring effect on the plaque, increasing the risk of postprocedural embolic events due to plaque prolapse. Maximum carotid plaque dilation before stent deployment may reduce this risk. This study analyzed the effect of maximum dilation of the carotid plaque before stent deployment (max-pre-SD) or after stent deployment (post-SD) on macroscopic plaque debris, hemodynamic depression (HD), and immediate major adverse events. METHODS: This prospective nonrandomized multicenter study analyzed patients treated for carotid artery stenosis with CAS from January 2014 to August 2016. Clinical and morphologic characteristics and operative details were analyzed with logistic regression analysis for macroscopic debris and HD. The number of microembolic signals (MESs) was assessed by transcranial Doppler and analyzed. RESULTS: A total of 309 patients were enrolled and treated with standard CAS performed using a proximal occlusion cerebral embolic protection device; 149 received max-pre-SD and 160 were treated with post-SD. Technical success was achieved in 100% of cases. Macroscopic debris and HD were significantly different between the two groups in favor of max-pre-SD (P < .001). A significant difference in intraprocedural MESs between the groups was detected. Compared with post-SD, max-pre-SD significantly reduced mean MES counts (8.1% vs 68.1%; P < .001). Patients treated with post-SD had a significantly increased risk of MESs in the immediate postoperative period compared with patients treated with max-pre-SD (41.9% vs 1.3%; P < .001).This result was mainly due to the small number of events encountered. Patients treated with post-SD had a 12-fold increased risk of macroscopic debris collection (odds ratio [OR], 12.36; 95% confidence interval [CI], 5.68-26.87; P < .001) and an 18 times increase in HD risk (OR, 17.80; 95% CI, 5.27-60.17; P < .001) compared with patients treated with max-pre-SD. The heterogeneous, mainly echolucent plaque type significantly highly increased the risk of macroscopic debris (OR, 78.45; 95% CI, 8.70-707.09; P < .001) while acting as a protective factor against HD (OR, 0.02; 95% CI, 0.006-0.11; P < .001) along with echogenic or echolucent complex plaques with irregular surface plaque types (OR, 0.10; 95% CI, 0.031-0.336; P < .001). No significant differences between groups (max-pre-SD group and post-SD) were detected in immediate major adverse events (minor stroke, 2.0% and 2.5% [P = .461]; major stroke, 0% and 0.6% [P = .334], respectively). CONCLUSIONS: Max-pre-SD seems to be a safe and feasible technical modification to the CAS procedure. Macroscopic debris, HD, and MESs are significantly reduced compared with CAS with post-SD. Further research with larger, randomized cohorts of patients is required to establish the superiority of this technical modification.


Assuntos
Estenose das Carótidas/terapia , Placa Aterosclerótica/terapia , Stents , Idoso , Idoso de 80 Anos ou mais , Angiografia , Estenose das Carótidas/diagnóstico por imagem , Dilatação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Placa Aterosclerótica/diagnóstico por imagem , Estudos Prospectivos , Acidente Vascular Cerebral/prevenção & controle , Ultrassonografia Doppler Transcraniana
16.
Eur J Vasc Endovasc Surg ; 59(3): 428-436, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31911139

RESUMO

OBJECTIVE: The aim of this study was to evaluate aortic remodelling and associated complications in patients treated by thoracic endovascular aneurysm repair (TEVAR) for blunt traumatic aortic injuries (BTAI). METHODS: This was a retrospective, observational, multicentre study. Remodelling was considered as aortic diameter variations of >2 mm and distal graft and aortic axis angle modification measured by computed tomography angiography (CTA). The predefined levels of measurement were the proximal end of the graft (D1: landing in zone [LZ] 2; D2: LZ 3); distal end (D3); and control measurement (D4) 15 mm beyond D3. Survival, procedure, graft, and/or radiation exposure related complications were registered. CTA was required within three months and at one, six, and 10 years post-operatively. RESULTS: Between 2004 and 2017 52 patients were treated; 47 were included for remodelling analysis (five immediate deaths were excluded); median age was 47 years (range 20-80 years). Mean TEVAR oversizing was 19.6% ± 9.7% (range 5%-35%). Following a median follow up of 67.4 ± 56.1 months (range 14-153 months) survival at one, three, six, and 10 years was 90.4% (standard error [SE] 4.1%), 88.3% (SE 4.5%) 84.8% (SE 5.5%), and 84.8% (SE 5.5%), respectively. There were no procedure/graft related complications except for one late intramural haematoma that required re-intervention. Freedom from aortic remodelling at one, six, and 10 years was 85.1% (SE 5.2%), 30.9% (SE 8.6%), and 24.7% (SE 8.8%), respectively. The increase in D1/D2 and D3 diameters were influenced by time from intervention (both p < .001), age (p < .001 and p = .002, respectively) and sealing in zone 2 (p = .027 and p = .042, respectively). For every 10% increase in oversizing, proximal neck diameter remodelling was 3.4% (p = .05). The distal axis decreased over time (p < .001; significant between three and six years). CONCLUSION: TEVAR is safe for BTAI in the mid to long term. This study reports a correlation between time, oversizing, and remodelling, but the level of adverse events was low.


Assuntos
Aorta Torácica/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Traumatismos Torácicos/cirurgia , Remodelação Vascular , Lesões do Sistema Vascular/cirurgia , Ferimentos não Penetrantes/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/lesões , Aorta Torácica/fisiopatologia , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Estudos Retrospectivos , Traumatismos Torácicos/diagnóstico por imagem , Traumatismos Torácicos/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Lesões do Sistema Vascular/diagnóstico por imagem , Lesões do Sistema Vascular/fisiopatologia , Ferimentos não Penetrantes/diagnóstico por imagem , Ferimentos não Penetrantes/fisiopatologia , Adulto Jovem
17.
Ann Vasc Surg ; 62: 275-286, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31445091

RESUMO

BACKGROUND: Venous percutaneous transluminal angioplasty (vPTA) in patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI) have shown contradictory results. The aim of the study is to evaluate the efficacy of the procedure in a randomized wait list control study. METHODS: 66 adults with neurologist-confirmed diagnosis of MS and sonographic diagnosis of CCSVI were allocated into vPTA-yes group (n = 31) or vPTA-not group (n = 35, control group). vPTA was performed immediately 15 days after randomization in the PTA-yes group and 6 months later in the control group. Evoked potentials (EPs), clinical-functional measures (CFMs), and upper limb kinematic measures (ULKMs) were measured at baseline (T0) and six months after in both groups, just before the venous angioplasty in the vPTA-not group (T1). RESULTS: Comparing the vPTA-yes and vPTA-not group, the CFM-derived composite functional outcome showed 11 (37%) versus 7 (20%) improved, 1 (3%) versus 3 (8%) stable, 0 versus 7 (20%) worsened, and 19 (61%) versus 18 (51%) mixed patients (χ2 = 8.71, df = 3, P = 0.03). Unadjusted and adjusted (for baseline confounding variables) odds ratio at 95% confidence interval were, respectively, 1.93 (1.3-2.8), P value 0.0007, and 1.85 (1.2-1.7), P value 0.002. EP- and ULKM-derived composite functional outcome showed no significant difference between the two groups. CONCLUSIONS: Venous angioplasty can positively impact a few CFMs especially for the quality of life but achieving disability improvement is unlikely.


Assuntos
Angioplastia , Veias Cerebrais , Transtornos Cerebrovasculares/terapia , Esclerose Múltipla Crônica Progressiva/terapia , Esclerose Múltipla Recidivante-Remitente/terapia , Extremidade Superior/inervação , Insuficiência Venosa/terapia , Adolescente , Adulto , Idoso , Angioplastia/efeitos adversos , Fenômenos Biomecânicos , Veias Cerebrais/diagnóstico por imagem , Veias Cerebrais/fisiopatologia , Transtornos Cerebrovasculares/diagnóstico por imagem , Transtornos Cerebrovasculares/fisiopatologia , Doença Crônica , Potencial Evocado Motor , Humanos , Itália , Pessoa de Meia-Idade , Esclerose Múltipla Crônica Progressiva/diagnóstico , Esclerose Múltipla Crônica Progressiva/fisiopatologia , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Esclerose Múltipla Recidivante-Remitente/fisiopatologia , Qualidade de Vida , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento , Insuficiência Venosa/diagnóstico por imagem , Insuficiência Venosa/fisiopatologia , Adulto Jovem
18.
J Vasc Surg ; 70(2): 478-484, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30718111

RESUMO

OBJECTIVE: Hand-assisted laparoscopic surgery (HALS) for the treatment of abdominal aortic aneurysm (AAA) has shown promising initial results compared with traditional surgery, but its efficacy remains highly debated. The aim of this monocentric, retrospective study was to investigate differences in morbidity, mortality, and reintervention rates between endovascular aneurysm repair (EVAR) and HALS, in the medium- and long-term follow-up in a highly selected population. METHODS: We treated 977 patients consecutively for nonurgent AAA from January 2006 to December 2013; among them, 615 (62.9%) underwent open surgery, 173 (17.7%) HALS, and 189 (19.3%) EVAR. For this study, only patients treated with HALS or EVAR were considered. A subsequent selection process was carried out to identify the patients with clinical characteristics and aneurysm morphology amenable to either of these treatments. The final study cohort included 229 patients; 92 (40.2%) underwent HALS and 137 (69.8%) received EVAR. The two populations were homogeneous for clinical and demographic characteristics. RESULTS: The mean duration of follow-up was 57 ± 28 months (50 ± 24 months in the EVAR group and 67 ± 29 months in the HALS group; range, 2-110 months). No deaths and no statistically significant differences in severe complications or reinterventions were observed over the perioperative period (30 days). Length of stay was significantly shorter after EVAR, because the need for and length of stay in the intensive care unit were decreased. Three postoperative deaths (in-hospital mortality >30 days: HALS, 2.2%; EVAR, 0.7%; P = .7268) occurred owing to respiratory failure (two patients, one in each group) and multiorgan failure secondary to a bowel ischemia (one patient in the HALS group). Other deaths in the study population were not related to the procedure. In both groups, the major causes of death were cancer (24 cases [36.9%]), cardiovascular causes unrelated to AAA (16 [24.6%]), and chronic obstructive lung disease (10 [15.4%]). In the long-term follow-up period, there was a difference in the overall survival in favor of HALS when compared with EVAR (P = .011). CONCLUSIONS: This retrospective, single-center study shows that, within a population of similar clinical and anatomic characteristics, treatment of AAA with EVAR or HALS does not result in significant differences in early morbidity and mortality. EVAR presents significantly shorter hospital and intensive care unit length of stay, whereas HALS presents a lower aneurysm-related reintervention rate and lower perioperative cost. The strict patient selection in this trial, as is generally the case with AAA treatment, is likely the key to success for both of these techniques.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Laparoscopia Assistida com a Mão , Idoso , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/economia , Aneurisma da Aorta Abdominal/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/economia , Implante de Prótese Vascular/mortalidade , Redução de Custos , Análise Custo-Benefício , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/economia , Procedimentos Endovasculares/mortalidade , Feminino , Laparoscopia Assistida com a Mão/efeitos adversos , Laparoscopia Assistida com a Mão/economia , Laparoscopia Assistida com a Mão/mortalidade , Custos de Cuidados de Saúde , Humanos , Tempo de Internação , Masculino , Complicações Pós-Operatórias/terapia , Retratamento , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
20.
Ann Vasc Surg ; 59: 310.e7-310.e11, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30802589

RESUMO

BACKGROUND: Intravesical instillation of Bacillus Calmette-Guérin (BCG) is an effective and widely used treatment for patients with in situ bladder cancer. Major complications are quite uncommon, but a systemic dissemination of the attenuated strain of Mycobacterium bovis is possible. Few cases of aortic rupture caused by M bovis infection are described in literature. METHODS: A 70-year-old male, treated 3 months before with BCG instillation, presented to the emergency department because of a ruptured abdominal aortic aneurysm. The patient was hemodynamically stable, with a "hostile" abdomen. Therefore, an Endologix AFX endograft was deployed. During the postoperative period, his blood inflammatory markers increased, suspicious of a graft infection. Single-photon emission computed tomography (CT)/CT scan showed aortic increased uptake. Antibiotic therapy was continued, but after some days, the patient presented with hematemesis, and the CT scan showed an aortoenteric fistula. In emergency, the infected graft and aneurysm were removed, enteric fistula was closed, and an axillobifemoral bypass was performed. The patient died 25 days after endovascular aneurysm repair explantation. RESULTS: Despite the high suspicion of mycotic aortic aneurysm and graft infection by M bovis, there is no proof of this theory because of the absence of any positive culture test. M bovis is a slow-growing bacteria, and specific culture tests are required to identify it; indeed, all our blood and intraoperative samples were positive to other bacteria, probably the contaminant ones. CONCLUSIONS: Mycotic aneurysm is an extremely rare complication of intravesical BCG therapy, but it must be taken into consideration in patients with rapidly growing aortic aneurysms or rupture of a normal aorta, who have been previously submitted to this kind of instillation.


Assuntos
Aneurisma Infectado/microbiologia , Antineoplásicos/efeitos adversos , Aneurisma da Aorta Abdominal/microbiologia , Ruptura Aórtica/microbiologia , Vacina BCG/efeitos adversos , Mycobacterium bovis/patogenicidade , Neoplasias da Bexiga Urinária/tratamento farmacológico , Administração Intravesical , Idoso , Aneurisma Infectado/diagnóstico por imagem , Aneurisma Infectado/cirurgia , Antibacterianos/uso terapêutico , Antineoplásicos/administração & dosagem , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/cirurgia , Aortografia/métodos , Vacina BCG/administração & dosagem , Angiografia por Tomografia Computadorizada , Evolução Fatal , Humanos , Masculino , Tomografia Computadorizada com Tomografia Computadorizada de Emissão de Fóton Único , Resultado do Tratamento
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