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Abstrak :
Latar belakang : Sejak munculnya EVAR pada 1990an, pengalaman dan teknologi mengenai stent garft semakin maju. Di RSCM pertama kali dilakukan pada tahun 2013. Menurut Ad Hoc Committee for Standarized Reporting Practices in Vascular Surgery of the Society for Vascular Surgery, keberhasilan teknis utama membutuhkan pengenalan sistem alat ini dengan baik. Sebelum melakukan tindakan EVAR, ahli bedah vaskular harus menilai severitas anatomi untuk disesuaikan dengan IFU dari Endurant Medtronics. Belum banyak penelitian yang menggambarkan hubungan antara kesesuaian teknis EVAR dengan IFU. Metode : Penelitian ini bersifat deskriptif analitik dengan design cross-sectional pada pasien yang menjalani EVAR oleh ahli bedah vaskular di Indonesia pada tahun 2013-2019. Data ditabulasi untuk mengetahui adanya hubungan antara implantasi prosedur EVAR sesuai IFU dengan technical intraoperating complication (TIC) pada pasien AAA, dilakukan uji Chi-Square jika distribusi data normal atau Mann-Whitney test jikadistribusi data tidak normal. Pengolahan data pada penelitian ini menggunakan program SPSS 20.0 untuk membantu perhitungan statistik. Hasil : Didapatkan 103 data aneurisma aorta abdominalis yang menjalani EVAR dari tahun 2013-2019. Terdapat 99 pasien (96.1%) pria dan 4 pasien (3.9%) wanita dan sebanyak 8 pasien (7.8%) berusia dibawah 60 tahun serta 95 pasien (92.2%) berusia diatas 60 tahun. Berdasarkan klasifikasi aortic neck severity score didapatkan 49 pasien (47.6%) memiliki klasifikasi ringan, 47 pasien (45.6%) dengan klasifikasi sedang, dan 7 pasien (6.8%) dengan klasifikasi berat. Berdasarkan klasifikasi total aortic anatomy severity score didapatkan 61 pasien (59.2%) dengan klasifikasi ringan, 42 pasien (40.8%) dengan klasifikasi sedang, dan 0 pasien (0%) dengan klasifikasi berat. Sebanyak 86 pasien (83.5%) prosedur EVAR dilakukan sesuai dengan IFU dan 17 pasien (16.5%) tidak sesuai dengan IFU. Dari data technical intraprocedure complication (TIC) didapatkan 19 pasien (18.4%) mengalami TIC dan 84 pasien (81.6%) tidak mengalami TIC. Dari penelitian ini didapatkan sebanyak 13 pasien (76.5%) yang tidak mengalami TIC dilakukan tindakan EVAR tidak sesuai IFU dan sesuai dengan IFU sebanyak 71 orang (82.6%). Sedangkan, sebanyak 4 pasien (23.5%) yang mengalami TIC dilakukan tidakan EVAR yang tidak sesuai IFU dan sebanyak 15 pasien (17,4%) yang mengalami TIC dilakukan tindakan EVAR sesuai dengan IFU. Pada data ini dihasilkan data OR (95% interval kepercayaan) sebesar 1.848 (0.385-8.864) dengan nilai p=0.556 Kesimpulan : Dari penelitian ini didapatkan hasil diameter leher proksimal, aortic neck severity score dan klasifikasi total aortic anatomyc severity secara independen memiliki hubungan yang signifikan dengan kejadian TIC pada pasien AAA di Indonesia tahun 2013-2019 dengan nilai p<0.05 dan secara umum skoring severitas anatomi memiliki pengaruh terhadap kejadian TIC setelah tindakan EVAR dan variasi anatomi menjadi pertimbangan untuk dilakukannya tindakan EVAR. Sedangkan faktor lainnya seperti panjang leher proksimal, angulasi aortic, kalsifikasi, trombus, usia, jenis kelamin, dan IFU secara independen tidak memiliki hubungan yang signifikan dengan kejadian TIC.

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Background. Since EVAR in the 1990s, the experience and technology of stent-graft has advanced. At the RSCM, it was first carried out in 2013. According to the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of the Society for Vascular Surgery, major technical success requires a good introduction to this system of tools. Before performing an EVAR procedure, vascular surgeons must assess the severity of the anatomy to match the IFU of Endurant Medtronics. Not many studies have described the relationship between EVAR's technical suitability and IFU. Method. This study is analytic with cross-sectional design in patients undergoing EVAR by vascular surgeons in Indonesia in 2013-2019. Data were tabulated to determine the relationship between implantation of the EVAR procedure according to IFU and technical intraoperative complication (TIC) in AAA patients, Chi-square test was performed if the data distribution was normal or the Mann -Whitney test if the data distribution was abnormal. Data processing in this study uses the SPSS 20.0 program to help statistical calculations. Results. 103 data obtained from abdominal aortic aneurysms undergoing EVAR from 2013-2019. There were 99 patients (96.1%) male and 4 patients (3.9%) female and as many as 8 patients (7.8%) aged under 60 years and 95 patients (92.2%) aged over 60 years. Based on the classification of aortic neck severity score, 49 patients (47.6%) had a mild classification, 47 patients (45.6%) with a moderate classification, and 7 patients (6.8%) with a severe classification. Based on the total aortic anatomy severity score classification, there were 61 patients (59.2%) with mild classification, 42 patients (40.8%) with moderate classification, and 0 patients (0%) with severe classification. A total of 86 patients (83.5%) EVAR procedures were performed following IFU and 17 patients (16.5%) did not comply with IFU. From technical intraoperative complication (TIC) data, 19 patients (18.4%) experienced TIC and 84 patients (81.6%) did not experience TIC. From this study, there were 13 patients (76.5%) who did not experience TIC. EVAR measures were not performed according to IFU and according to IFU, there were 71 people (82.6%). Meanwhile, as many as 4 patients (23.5%) who experienced TIC were performed EVAR actions that were not IFU compliant and as many as 15 patients (17.4%) who experienced TIC were performed EVAR measures according to IFU. In this data generated OR data (95% confidence interval) of 1,848 (0.385-8,864) with a value of p = 0.556 Conclusion. From this study the results obtained proximal neck diameter, aortic neck severity score and total classification of aortic anatomic severity independently have a significant relationship with the incidence of TIC in AAA patients in Indonesia in 2013-2019 with a p-value <0.05 and in general the scoring of anatomical severity has an influence the occurrence of TIC after the EVAR procedure and anatomic variations are considered for the EVAR procedure. While other factors such as proximal neck length, aortic angulation, calcification, thrombus, age, sex, and IFU independently did not have a significant relationship with the incidence of TIC.

Abstrak :
Latar Belakang: Endovascular repair of abdominal aortic aneurysms (EVAR) menggunakan stent graft merupakan terapi utama pada pasien dengan aneurisma aorta abdominal. Aplikasi klinis EVAR dihadapkan dengan tingginya variasi anatomik aneurisma yang menyebabkan ketidaksesuaian ukuran stent yang dapat menyebabkan komplikasi berupa endoleak. Pembuatan instructions for use (IFU) merupakan upaya standardisasi dari produsen stent sehingga dapat sesuai dengan kondisi anatomik pasien dan menghindari komplikasi. Belum adanya penelitian mengenai kesesuaian IFU pada EVAR dan keluaran operasinya khususnya endoleak pasca-EVAR. Penelitian ini ditujukan untuk melihat hubungan kesesuaian IFU pada EVAR dengan kejadian endoleak pasca-EVAR. Metode: Studi dilakukan secara kohort retrospektif yang menilai hubungan kesesuaian IFU pada EVAR dengan kejadian endoleak pasca-EVAR. Penelitian akan dilakukan dari bulan Desember 2018-Februari 2019 di Rumah Sakit dr. Cipto Mangunkusumo (RSCM). Pengambilan subjek dilakukan dengan pengambilan subjek total. Hasil: Pada pengambilan subjek didapatkan 39 subjek yang menjalani prosedur EVAR. Pada penelitian ini didapatkan 27 subjek (69.2%) menjalani EVAR sesuai dengan IFU dan 12 subjek (30.8%) tidak sesuai dengan IFU. Pada penelitian ini didapatkan 3 subjek penelitian (7.7%) mengalami endoleak pasca-EVAR. Pada analisis data, ditujukan bahwa kesesuaian IFU dalam menjalani EVAR tidak menunjukan hubungan yang bermakna dengan kejadian endoleak pasca-EVAR (p=0.539). Pada penelitian ini didapatkan bahwa seluruh pasien yang mengalami endoleak pasca-EVAR berasal dari kelompok yang menjalankan IFU yang sesuai. Analisis data panjang, sudut, dan diameter leher juga tidak menunjukan hubungan yang bermakna dengan kejadian endoleak pasca-EVAR. Kesimpulan: Tidak terdapat adanya hubungan antara kesesuaian IFU dalam menjalani EVAR dengan kejadian endoleak pasca-EVAR.

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Background: Endovascular repair of abdominal aortic aneurysms (EVAR) with stent-graft is the main treatment for patients with abdominal aortic aneurysm. Clinical application of EVAR is faced with the wide anatomic variety of aneurysm that could lead to incompatibility of stent size that could cause complications like endoleak. Instruction of use (IFU) is a standardization effort from the producer of the stent so that it would be more suitable for the patients anatomical condition thus avoiding the complications. Up until now, there has not been a research that studied the use of IFU on EVAR and its post-surgical outcome, especially post-EVAR endoleak. The objective of this study is to see the association between IFU accordance in EVAR with post-EVAR endoleak. Method: The study was conducted by cohort-retrospective which assesses the association between IFU accordance in EVAR with post-EVAR endoleak. This study was done from December 2018 to February 2019 at vascular surgery out-patient clinic in Cipto Mangunkusumo Hospital. Total sampling was conducted to obtain subjects by collecting all patients treated by EVAR. Results: There were 39 subjects selected in this study. We found 27 subjects (69.2%) underwent EVAR appropriately according to IFU and 12 subjects (30.8%) that did not. Three of the subjects (7.7%) had post-EVAR endoleak. In the data analysis, IFU accordance in EVAR did not have a significant association with post-EVAR endoleak incidence (p=0.539). This study also found that every single subject with post-EVAR endoleak was from the IFU appropriate EVAR group. Data analysis on neck length, angle, and diameter also did not show any significant association with post-EVAR endoleak incidence (p>0.05). Conclusion: There is no association between IFU accordance in EVAR with post-EVAR endoleak. Another study with larger sample size is needed to show association between IFU accordance with post-EVAR endoleak more accurately.