Browsing by Author "Rijn, MJ"
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- Alterações Morfológicas e Consequências Clínicas do Tratamento de Colos Proximais Largos Requerendo Endopróteses com 34-36mm de DiâmetroPublication . Oliveira-Pinto, J; Soares Ferreira, R; Oliveira, N; Bastos Gonçalves, F; Hoeks, S; Rijn, MJ; Raa, S; Mansilha, A; Verhagen, HIntrodução: O tratamento endovascular representa o método de eleição para o tratamento de Aneurismas da Aorta Abdominal (AAA). Existem endopróteses disponíveis com diâmetros do colo proximal até 36mm, que permitem o tratamento de colos proximais até 32 mm. Contudo, a existência de colos largos representa um conhecido preditor de complicações. O objetivo deste estudo é avaliar os resultados a médio-prazo de doentes que requereram endopróteses de 34-36mm. Métodos: Foi realizada uma análise retrospetiva de uma base de dados prospetiva, incluindo todos os pacientes submetidos a EVAR por AAA degenerativo numa instituição terciária na Holanda. Todas as medições foram realizadas em reconstruções center-lumen line em software dedicado. Os pacientes foram classificados como “diâmetro largo” (LD), se a endoprótese implantada tivesse diâmetro superior a 32 mm.. Os restantes pacientes foram classificados como diâmetro normal (ND). O endpoint primário foi complicações relacionadas com o colo (combinação de endoleak tipo IA, migração>5mm ou qualquer intervenção no colo proximal). Alterações morfológicas no colo e sobrevida foram também analisadas. Diferenças entre grupos foram ajustadas por regressão multivariável. Resultados: O estudo incluiu 502 pacientes (90 no grupo LD e 412 no grupo ND). O follow-up mediano foi de 3.5 anos IQR (1.5–6.2) e 4.5 anos IQR (2.1–7.3) para os grupos LD e ND, respetivamente, P=.008. Relativamente às características basais, os doentes no grupo LD, apresentavam maior incidência de hipertensão arterial (83% vs 69.7%, P=.012) e tabagismo (86% vs 84.1%, P=.018). Além de colos mais largos (colo Proximal Ø > 28 mm: 75% vs 3.3%, P<.001), os indivíduos do grupo LD apresentavam também colos mais angulados (ângulo-α >45º: 21% vs 9%, P=.002), cónicos (39.8% vs 20.3%, P<.001) e com maior proporção de trombo circunferencial (Trombo no colo >25%: 42% vs 32.3%, P<.089). O oversizing foi maior entre o grupo LD (20% [12.5–28.8] vs 16.7% [12–21.7], P=.008). Todas os restantes detalhes anatómicos eram semelhantes entre grupos. A ausência de complicações relacionadas com o colo aos 5 anos foi de 73% no grupo LD e de 85% no grupo ND, P=.001. Endoleak tipo 1A foi mais comum no grupo LD (12.2% vs 5.1%, P=.003). Migração>5 mm ocorreu similarmente entre grupos (7.8% vs 5.1%, P=.32). Reintervenções relacionadas com colo o foram também mais frequentes no grupo LD (13.3% vs 8.7%, P=.027).
- Comparison of Midterm Results of Endovascular Aneurysm Repair for Ruptured and Elective Abdominal Aortic AneurysmsPublication . Oliveira-Pinto, J; Soares Ferreira, R; Oliveira, N; Bastos Gonçalves, F; Hoeks, S; Rijn, MJ; Raa, S; Mansilha, A; Verhagen, JMObjective: Endovascular aneurysm repair (EVAR) became an increasingly preferred modality for abdominal aortic aneurysm (AAA) repair both in elective AAA repair (el-EVAR) and EVAR of a ruptured AAA (r-EVAR) setting. Ruptured AAAs usually have more hostile anatomies and less time for planning. Consequently, more complications may arise after r-EVAR. The purpose of this study was to compare mi-term outcomes between r-EVAR and el-EVAR. Methods: A retrospective cohort analysis of patients undergoing EVAR from 2000 to 2015 at a tertiary institution was performed. Patients with previous aortic surgery, nonatherosclerotic AAA and isolated iliac aneurysms were excluded. In-hospital casualties or patients who were intraoperatively converted to open repair were also excluded. For the midterm outcome analysis, only patients with at least two postoperative examinations (a 30-day computed tomography scan and a second postoperative examination performed 6 months or later) were considered. The primary end point was freedom from aneurysm-related complications (a composite of type I or III endoleak, aneurysm sac growth, migration of more than 5 mm, device integrity failure, AAA-related death, late postimplant rupture, or AAA-related secondary intervention). Freedom from secondary interventions, neck-related events (defined as a composite of type IA endoleak, migration of more than 5 mm, or preemptive neck-related secondary intervention) and late survival were secondary end points. The impact of device instructions for use (IFU) compliance on neck events was also assessed. Results: The study included 565 patients (65 r-EVAR and 500 el-EVAR). Eighty-two patients were treated outside proximal neck IFU, 13 in the r-EVAR group (21.3%) and 69 (14.5%) in the el-EVAR (P = .16). During the index hospitalization, there were more complications (12.3% vs 3.2%; P = .001) and reinterventions (12.3% vs 2.8%; P < .001) in the r-EVAR group. After discharge, median clinical follow-up time was 4.3 years (interquartile range, 2.1-7.0 years) without differences between both groups. Five-year freedom from AAA-related complications was 53.9% in the r-EVAR group and 65.4% in the el-EVAR (P = .21). In multivariable analysis the r-EVAR group was not at increased risk for late complications (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.54-1.61; P = .81). Five-year freedom from neck-related events was 74% in r-EVAR and 82% in the el-EVAR group (P = .345). Patients treated outside neck IFU were at greater risk for neck-related events both in r-EVAR (HR, 6.5; 95% CI, 1.8-22.9; P = .004) and el-EVAR group (HR, 2.6; 95% CI, 1.5-4.5; P < .001). Freedom from secondary interventions at 5 years was 63.0% for r-EVAR and 76.9% for el-EVAR (P = .16). Survival at 5 years was 68.8% in the r-EVAR group and 73.3% in the el-EVAR group (P = .30). Conclusions: Durable and sustainable midterm outcomes were found for both r-EVAR and el-EVAR patients who survived the postoperative period. Patients treated outside the IFU are at greater risk for late complications. Surveillance protocols may be tailored according to individual anatomy and IFU compliance rather than timing of repair.
- Long-Term Results After Standard Endovascular Aneurysm Repair With the Endurant and Excluder Stent GraftsPublication . Oliveira-Pinto, J; Oliveira, N; Bastos Gonçalves, F; Hoeks, S; Rijn, MJ; Raa, S; Mansilha, A; Verhagen, HObjective: Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts. Methods: Patients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points. Results: The study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (β-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39). Conclusions: This study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.
- Patients with Large Neck Diameter Have a Higher Risk of Type IA Endoleaks and Aneurysm Rupture after Standard Endovascular Aneurysm RepairPublication . Oliveira, N; Bastos Gonçalves, F; Ultee, K; Pinto, JP; Rijn, MJ; Raa, S; Mwipatayi, P; Böckler, D; Hoeks, S; Verhagen, HObjective: Standard endovascular aneurysm repair (EVAR) is the most common treatment of abdominal aortic aneurysms (AAAs). EVAR has been increasingly used in patients with hostile neck features. This study investigated the outcomes of EVAR in patients with neck diameters ≥30 mm in the prospectively maintained Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Methods: This is a retrospective study comparing patients with neck diameters ≥30 mm with patients with neck diameters <30 mm. The primary end point was type IA endoleak (EL1A). Secondary end points included secondary interventions to correct EL1A, aneurysm rupture, and survival. Results: This study included 1257 patients (mean age, 73.1 years; 89.4% male) observed for a median 4.0 years (interquartile range, 2.7-4.8 years). A total of 97 (7.7%) patients had infrarenal neck diameters ≥30 mm and were compared with the remaining 1160 (92.3%) with neck diameters <30 mm. At baseline, there were no differences between groups regarding demographics and comorbidities other than cardiac disease, which was more frequent in the ≥30-mm neck diameter group (P = .037). There were no significant differences between the groups regarding neck length, angulation, thrombus, or calcification. Mean preoperative AAA diameter was 64.6 ± 11.3 mm in the ≥30-mm neck diameter group and 60.0 ± 11.6 mm in the <30-mm neck diameter group (P < .001). Stent graft oversizing was significantly less in the ≥30-mm neck diameter group (12.2% ± 8.9% vs 22.1% ± 11.9%; P <. 001). Five patients (5.2%) in the ≥30-mm neck diameter group and 30 (2.6%) with neck diameters <30 mm developed EL1A, yielding a 4-year freedom from EL1A of 92.4% vs 96.6%, respectively (P = .09). Oversizing was 21.8% ± 13.0% for patients developing EL1A and 21.3% ± 12.4% for the remaining cohort (P = .99). In adjusting for neck length, AAA diameter, and device oversizing, patients with neck diameter ≥30 mm were at greater risk for development of EL1A (hazard ratio, 3.0; 95% confidence interval, 1.0-9.3; P = .05). Secondary interventions due to EL1A did not differ between groups (P = .36). AAA rupture occurred in three patients with neck diameter ≥30 mm (3.1%) and in eight patients with neck diameter <30 mm (0.7%; hazard ratio, 5.1; 95% confidence interval, 1.4-19.2; P = .016); two cases were EL1A related in each group. At 4 years, overall survival was 61.6% for the ≥30-mm neck diameter group and 75.2% for the <30-mm neck diameter group (P = .009), which remained significant on correcting for sex and AAA diameter (P = .016). Conclusions: In this study, patients with infrarenal neck diameter ≥30 mm had a threefold increased risk of EL1A and fivefold risk of aneurysm rupture after EVAR as well as worse overall survival. This may influence the choice of AAA repair and underlines the need for regular computed tomography-based imaging surveillance in this subset of patients. Furthermore, these results can serve as standards with which new, possibly improved technology, such as EndoAnchors (Medtronic, Santa Rosa, Calif), can be compared.