Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study

Abstract

Purpose:

Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study.

Materials and Methods:

Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory.

Results:

The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively.

Conclusions.

In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years.

Clinical Impact

Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.

ClinicalTrials.gov Identifier: NCT02477111.

Keywords

endovascular repair infrarenal abdominal aortic aneurysm low-profile stent graft durability

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References

Powell

Sweeting

Ulug

, et al. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017;104(3):166–178. doi:10.1002/bjs.10430.

Yokoyama

Kuno

Takagi

Meta-analysis of phase-specific survival after elective endovascular versus surgical repair of abdominal aortic aneurysm from randomized controlled trials and propensity score-matched studies. J Vasc Surg. 2020;72(4):1464–1472. doi:10.1016/j.jvs.2020.03.041.

Qin

Perera

Papa

, et al. Open versus endovascular abdominal aortic aneurysm repair in the Australian private sector over twenty years. J Endovasc Ther. 2021;28(6):844–851. doi:10.1177/15266028211028215.

Lijftogt

Vahl

Karthaus

, et al. Effects of hospital preference for endovascular repair on postoperative mortality after elective abdominal aortic aneurysm repair: analysis of the Dutch Surgical Aneurysm Audit. BJS Open. 2021;5(3): zraa065. doi:10.1093/bjsopen/zraa065.

Murray

Ghosh

Khwaja

, et al. Access for endovascular aneurysm repair. J Endovasc Ther. 2006;13(6):754–761. doi:10.1583/06-1835.1.

Cuypers

Laheij

Buth

Which factors increase the risk of conversion to open surgery following endovascular abdominal aortic aneurysm repair? The EUROSTAR collaborators. Eur J Vasc Endovasc Surg. 2000;20(2):183–189. doi:10.1053/ejvs.2000.1167.

Erbel

Aboyans

Boileau

, et al. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The task force for the diagnosis and treatment of aortic diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014;35(41):2873–2926. doi:10.1093/eurheartj/ehu281.

Kristmundsson

Sonesson

Dias

, et al. Anatomic suitability for endovascular repair of abdominal aortic aneurysms and possible benefits of low profile delivery systems. Vascular. 2014;22(2):112–115. doi:10.1177/1708538112473980.

Coppi

Njila

Coppi

, et al. INCRAFT(R) Stent-Graft System: one-year outcome of the INNOVATION Trial. J Cardiovasc Surg (Torino). 2014;55(1):51–59.

10.

Pratesi

Chiesa

, et al. The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT(R) AAA stent-graft system for endovascular repair. J Cardiovasc Surg (Torino). 2017;58(5):650–657. doi:10.23736/s0021-9509.17.09305-3.

11.

Scheinert

Pratesi

Chiesa

, et al. First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial. J Vasc Surg. 2013;57(4):906–914. doi:10.1016/j.jvs.2012.09.079.

12.

Torsello

Pratesi

van der Meulen

, et al. Aortoiliac remodeling and 5-year outcome of an ultralow-profile endograft. J Vasc Surg. 2019;69(6):1747–1757. doi:10.1016/j.jvs.2018.09.059.

13.

Liang

Ohki

Ouriel

, et al. Five-year results of the INSPIRATION study for the INCRAFT low-profile endovascular aortic stent graft system. J Vascr Surg. 2021;73(3):867–873.e2. doi:10.1016/j.jvs.2020.06.128.

14.

Georgiadis

Chatzigakis

Kouvelos

, et al. Multicenter mid-term results after endovascular aortic aneurysm repair with the Incraft® device. Ann Vasc Surg. 2021;72:464–478. doi:10.1016/j.avsg.2020.09.018.

15.

Zavatta

Squizzato

Balestriero

, et al. Early and midterm outcomes of endovascular aneurysm repair with an ultra-low-profile endograft from the Triveneto Incraft Registry. J Vasc Surg. 2021;73(6):1950–1957. doi:10.1016/j.jvs.2020.09.044.

16.

Torsello

Bertoglio

Kellersmann

, et al. One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms. J Vasc Surg. 2022;75(6):1904–1911.e3. doi:10.1016/j.jvs.2021.12.066.

17.

Chaikof

Dalman

Eskandari

, et al. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018;67(1):2–77.e2. doi:10.1016/j.jvs.2017.10.044.

18.

Chaikof

Blankensteijn

Harris

, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35(5):1048–1060. doi:10.1067/mva.2002.123763.

19.

Chaikof

Fillinger

Matsumura

, et al. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair. J Vasc Surg. 2002;35(5):1061–1066. doi:10.1067/mva.2002.123991.

20.

Stomp

Dierikx

Wever

, et al. Percutaneous EVAR for ruptured abdominal aortic aneurysms using the Cordis INCRAFT endograft. Ann Vasc Surg. 2022;79:273–278. doi:10.1016/j.avsg.2021.07.018.

21.

Bersin

The evolution of low-profile endograft design. Endovascular Today. March 2011:54–58.

22.

Clough

Hertault

Azzaoui

, et al. Low profile EVAR. Endovascular Today. March 2016:72–74.

23.

Myers

Wolf

Product development and business implications: the endurant EVO experience. In: Cheng

,ed. Handbook of Vascular Motion. Cambridge, MA: Academic Press; 2019:352–357.

24.

Verzini

Cieri

Kahlberg

, et al. A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms. J Vasc Surg. 2021;74(4):1125–1134. doi:10.1016/j.jvs.2021.04.018.

25.

Bogdanovic

Stackelberg

Lindström

, et al. Limb graft occlusion following endovascular aneurysm repair for infrarenal abdominal aortic aneurysm with the Zenith alpha, excluder, and endurant devices: a multicentre cohort study. Eur J Vasc Endovasc Surg. 2021;62(4):532–539. doi:10.1016/j.ejvs.2021.05.015.

26.

Mufty

Houthoofd

Daenens

, et al. Mid- to long-term outcome results of the Ovation stent graft. Ann Vasc Surg. 2020;63:129–135. doi:10.1016/j.avsg.2019.06.045.

27.

Oderich

Farber

Schneider

, et al. Final 5-year results of the United States Zenith Fenestrated prospective multicenter study for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2021;73(4):1128–1138.e2. doi:10.1016/j.jvs.2020.08.128.

28.

Teijink

JAW

Power

Böckler

, et al. Editor’s choice—five year outcomes of the endurant stent graft for endovascular abdominal aortic aneurysm repair in the ENGAGE registry. Eur J Vasc Endovasc Surg. 2019;58(2):175–181. doi:10.1016/j.ejvs.2019.01.008.

29.

Egorova

Vouyouka

McKinsey

, et al. Effect of gender on long-term survival after abdominal aortic aneurysm repair based on results from the Medicare national database. J Vasc Surg. 2011;54(1):1–12.e6. doi:10.1016/j.jvs.2010.12.049.

30.

Erben

Bews

Hanson

, et al. Female sex is a marker for higher morbidity and mortality after elective endovascular aortic aneurysm repair: a national surgical quality improvement program analysis. Ann Vasc Surg. 2020;69:1–8. doi:10.1016/j.avsg.2020.06.031.

31.

Sobocinski

Briffa

Holt

, et al. Evaluation of the Zenith low-profile abdominal aortic aneurysm stent graft. J Vasc Surg. 2015;62(4):841–847. doi:10.1016/j.jvs.2015.04.452.

32.

Lemmon

Motaganahalli

Chang

, et al. Failure mode analysis of the endologix endograft. J Vasc Surg. 2016;64(3):571–576. doi:10.1016/j.jvs.2016.03.416.

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