Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion
Abstract
:1. Introduction
2. Material and Methods
2.1. Search Strategy
2.2. Study Selection: Study Design and Data Extraction
2.3. Outcomes
2.4. Statistical Analysis
3. Results
3.1. Study Characteristics
3.2. Technical Success and Adjunctive Procedures
3.3. Thirty-Day Results
3.4. Mid-Term Follow-Up Results
4. Discussion
4.1. Ethical Considerations
4.2. Study Limitations
4.3. Conclusions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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First Author | Year of Publication | Country | Study Period | Number of Patients | Mean Follow-Up (Month) | Hostile Neck Anatomy Definition | Implanted Endografts | Mean Age (Years) | Technical Success (%) | Need for Adjunctive Procedures (%) |
---|---|---|---|---|---|---|---|---|---|---|
Dillavou ED [24] | 2003 | United States of America | 1999–2002 | 91 | 18 | short neck <10 mm; bulge: focal enlargement of the aneurysm neck; reverse taper: dilation >2 mm within the first 10 mm; angulated neck >60 degrees; significant neck thrombus covering > 50% of the circumference | Ancure | 75.7 | 95.61 | 4.39 |
Fairman RM [25] | 2004 | United States of America | NA | 153 | 21 | short neck: <15 mm; very short neck: <10 mm, dilated neck >28 mm, angulated neck > 45 degrees; calcified, and thrombus-lined, with or without ulceration | Talent | NA | NA | NA |
Choke E [26] | 2006 | United Kingdom | 1997–2005 | 60 | 21.7 | short neck:< 10 mm; wide neck: >28 mm; angulated neck: >60 degrees; significant neck thrombus covering > 50% of the circumference | AneuRX, Excluder, Zenith, Talent, Fortron, Endofit, Vanguard, Lifepath | 74.4 | 98 | 18 |
Cox DE [27] | 2006 | United States of America | 2000–2004 | 19 | 12 | short neck: <15 mm; wide neck: >26 mm; angulated neck: >60 degrees; circumferential neck thrombus; neck bulge; reverse taper neck: dilated >2 mm within 10 mm | Zenith, Aneurx | 72 | 100 | 15.78 |
Mc Donnell CO [28] | 2006 | Australia | 2001–2004 | 46 | 20.2 | Flared neck; Barrel neck; cone neck; irregular neck; hourglass neck | Talent, Zenith | NA | NA | NA |
Abbruzzese TA [29] | 2008 | United States of America | 1999–2005 | 222 | 29.6 | any deviation from single-device IFU | Zenith, Excluder, AneuRX | NA | NA | NA |
Chisci E [30] | 2009 | Italy, Sweden | 2005–2007 | 74 | 19 | neck diameter >28 mm; neck length <15 mm, neck angulation >60 degrees; reverse, tapered or bulging neck, circumferential neck thrombus >50% | Talent, Zenith | 77.5 | 95.9 | 41.9 |
Jim J [31] | 2010 | United States of America | 2002–2003 | 53 | 60 | wide neck: diameter >28 mm; angulated neck: >60 degrees; short neck: length <15 mm; significant thrombus: >50% of neck circumference; reverse tapered neck: neck dilated >2 mm within 10 mm; neck bulge: focal neck enlargement >3 mm within 15 mm | Talent | 76.5 | 96.2 | 0 |
Troisi N [32] | 2010 | Germany | 2007–2009 | 106 | 9 | short neck: <10 mm; neck bulge: focal dilatation >3 mm within 15 mm; tapered neck: enlargement >2 mm within 10 mm; angulated neck: >60 degrees; neck thrombus: >50% of neck circumference | Endurant | 73.6 | 100 | 9 |
Aburahma AF [33] | 2011 | USA | 2004–2010 | 149 | 22 | short neck: <10 mm; angulated neck: >60 degrees; wide diameter: >28 mm; calcified neck: >50% of neck circumference; neck thrombus: >2 mm thick; reverse tapered neck: neck dilatation >2 mm within the first 10 mm | AneuRX, Excluder, Zenith, Talent | 74.3 | 99 | 22 |
Georgiadis GS [34] | 2011 | Greece | 2009–2010 | 34 | 12.44 | neck length between 5 and 12 mm; neck angulation between 60 and 90 degrees | Endurant | 72.8 | 100 | 8.8 |
Hoshina K [35] | 2011 | Japan | 2006–2008 | 49 | 26 | short neck: <15 mm; angulated neck: >60 degrees | Zenith, Excluder | NA | NA | 51 |
Hyhlik-Dürr A [36] | 2011 | Germany | 2008–2009 | 50 | 15 | short neck: <15 mm | Endurant | 75 | 96 | 4 |
Rouwet EV [37] | 2011 | International | 2007–2008 | 80 | 12 | infrarenal angulation >60 degrees | Endurant | 76 | 100 | 0 |
Torsello G [38] | 2011 | Germany | 2007–2010 | 56 | 12 | short neck: <10 mm; angulated neck: >60 degrees | Endurant | 75.3 | 100 | 1.8 |
Van Keulen JW [39] | 2011 | The Netherlands | 2007–2009 | 19 | 12 | any deviation from single-device IFU | Endurant | 73 | 100 | 0 |
Lee M [40] | 2012 | Republic of Korea | 2007–2010 | 19 | 18.7 | angulated neck: >60 degrees; conical neck: diameter at 15 mm below the lowest renal artery >10% larger than the diameter at the lowest renal artery | Zenith, Talent | 73.3 | 100 | NA |
Hager ES [41] | 2012 | United States of America | 2002–2009 | 84 | 18.5 | short neck: <15 mm | Excluder, Zenith | 75.5 | 100 | 16.6 |
Kvinlaug KE [42] | 2012 | Canada | 2008–2010 | 37 | 6 | short neck: <15 mm; wide neck: >28 mm; angulated neck: >60 degrees | Endurant | 75.3 | 100 | NA |
Setacci F [43] | 2012 | Italy | 2010 | 72 | 1 | hourglass neck; angulated neck: >60 degrees; short neck: <15 mm; thrombosed neck: >50% of the neck circumference; reverse conical neck: dilatation > 2 mm within 10 mm; barrel neck: focal enlargement >3 mm within 15 mm | Endurant | 77 | 100 | 11.11 |
Stather PW [44] | 2012 | United Kingdom | 1999–2010 | 199 | 48 | angulated neck: >60 degrees; short neck: <15 mm; wide neck: >28 mm; thrombosed neck; flared neck | Zenith, Talent, Excluder, Endurant, Jotec Tube | 73.9 | 98 | NA |
Antoniou GA [45] | 2013 | International | NA | 60 | 18 | short neck: <15 mm; angulated neck: >60 degrees | Endurant, Zenith | 74 | 100 | 8 |
Mwipatayi BP [46] | 2013 | Australia | 2008–2011 | 31 | 20 | short neck: <10 mm; angulated neck: >60 degrees; reverse tapered neck: diameter >2 mm for every 5 mm distal from the most caudal renal artery | Endurant | 75 | 100 | 12.9 |
Shintan T [47] | 2013 | Japan | 2007–2011 | 20 | 25.7 | short neck: <10 mm; angulated neck: >60 degrees; reverse tapered neck: dilation >2 mm within the first 10 mm; thrombosed neck: thrombus in the first 10 mm of the neck, with thickness >2 mm and covering >25% of the circumference | Excluder, Zenith | 75.6 | 100 | 10 |
Ierardi AM [48] | 2014 | Italy | 2009–2011 | 36 | 27.7 | short neck: between 7 and 10 mm | Ovation | 73.6 | 100 | 0 |
Igari K [4] | 2014 | Japan | 2008–2010 | 12 | 25 | short neck: <15 mm; angulated neck: >60 degrees | Excluder, Zenith, Powerlink | 77.5 | NA | 0 |
Iwakoshi S [49] | 2014 | Japan | 2009–2011 | 44 | 120 | short neck: <15 mm; angulated neck: >60 degrees; reverse tapered neck: dilation >2 mm within the first 10 mm | Zenith | 77 | 92.1 | 16 |
Setacci F [50] | 2014 | Italy | 2010 | 72 | 24 | hourglass neck; angulated neck: >60 degrees; short neck: <15 mm; thrombosed neck: >50% of the neck circumference; reverse conical neck: dilatation > 2 mm within 10 mm; barrel neck: focal enlargement >3 mm within 15 mm | Endurant | 77 | NA | NA |
Speziale F [7] | 2014 | Italy | 2010–2011 | 133 | 24 | noncylindrical neck: hourglass, reverse conical neck (dilation > 2 mm within 10 mm), or barrel neck (focal enlargement >3 mm within 15 mm); angulated neck: >65 degrees; short neck <15 mm, wide neck: >28 mm | Endurant, Excluder, Zenith | NA | 100 | 12 |
Kaladji A [51] | 2015 | France | 1998–2012 | 170 | 38 | wide neck: need for a stent graft >32 mm in diameter | Talent, Zenith, Excluder, Anaconda, Endurant, Vanguard, AFX, AneuRx, Zenith, Lifepath | 75 | 100 | 0 |
Saha P [52] | 2015 | United Kingdom | 2006–2008 | 27 | 72 | wide neck: need for a stent graft >36 mm in diameter | Zenith | 76 | 93 | 0 |
Cerini P [53] | 2016 | Italy | 2005–2013 | 90 | 37 | any deviation from single-device IFU | Zenith, Endurant, Evita | 75.8 | 95.3 * | 1.1 |
de Donato G [54] | 2016 | Italy | 2010–2012 | 161 | 32 | short neck: >7 mm; thrombosed neck: >50% of the neck circumference; calcified neck: >50% of the neck circumference | Ovation | 75.2 | 99.3 | 0.6 |
Gallitto E [55] | 2016 | Italy | 2005–2010 | 60 | 51.4 | short neck: <10 mm | Zenith, Endurant | 74.9 | 95 * | 7 |
Gimenez-Gaibar A [5] | 2016 | Spain | 2006–2013 | 52 | 24 | short neck: 15 mm; angulated neck: >60 degrees thrombosed neck: >50% of the neck circumference; calcified neck: >50% of the neck circumference | Excluder, Talent, Anaconda, Zenith, Endurant | 75.9 | 100 | 13.4 |
Sirignano P [56] | 2016 | Italy | 2012–2014 | 21 | 9 | noncylindrical neck: hourglass, reverse conical (dilated >2 mm within 10 mm, barrel (focal enlargement >3 mm within 15 mm); angulated neck: >65 degrees; short neck: <10 mm; enlarged neck: diameter >30 mm; thrombosed neck: mural thrombosis >3 mm | Ovation | 75.6 | 100 | 0 |
de Donato G [57] | 2017 | Italy | 2010–2012 | 89 | 32 | short neck: <7 mm | Ovation | 76.4 | 97.7 | 2.2 |
Gargiulo M [58] | 2017 | International | 2009–2012 | 118 | 37.9 | wide neck: >28 mm | Zenith, Endurant, Excluder, Ovation, Anaconda | 73.9 | 98 | 5 |
Kontopodis N [59] | 2017 | Greece | NA | 106 | 18 | short neck: >7 mm | Ovation | NA | 97.2 | 0 |
Lee JH [60] | 2017 | Republic of Korea | 2010–2013 | 38 | 1 | conical neck: neck coefficient calculated using the following formula (diameter, D): Arctangent ([D3-D1]/[neck length]) × 180/π, if the absolute value of the neck coefficient was >10, it was defined as conical or inverted conical | Zenith, Endurant | 73.8 | 100 | 23.7 |
Pitoulias GA [61] | 2017 | International | 2007–2015 | 156 | 41.1 | short neck: <15 mm; angulated neck: >60 degrees; wide neck: <32 mm; circumferential thrombus with >2-mm thickness; circumferential calcification >50%; reverse tapered neck: neck dilation >2 mm within 10 mm; neck bulge | Endurant | 73.4 | 100 | 2.5 |
Sirignano P [62] | 2017 | Italy | 2012–2015 | 156 | 20.4 | short neck: <10 mm; noncylindrical aortic neck | Ovation | 74.83 | 100 | 10.25 |
Reyes Valdiva A [63] | 2017 | International | 2007–2015 | 73 | 30 | need for a stent graft >36 mm in diameter; any deviation from single-device IFU | Endurant | 74.4 | 98.6 | 6.8 |
Aburahma AF [10] | 2018 | United States of America | 2003–2015 | 33 | 31.8 | wide neck: >31 mm | Excluder, Zenith, AneuRX | 74.7 | 100 | NA |
Bryce Y [64] | 2018 | United States of America | 2004–2013 | 125 | 47.3 | short neck: <10 mm; angulated neck: >60 degrees; reverse conical neck (neck dilated > 2 mm within 10 mm, barrel neck (focal enlargement > 3 mm within 15 mm); thrombosed neck: >50% of the neck circumference; calcified neck: >50% of the neck circumference | Endurant, Excluder, Zenith, Ovation, AFX | 75.4 | 100 | 20 |
Greaves NS [65] | 2018 | United Kingdom | 2012–2017 | 52 | 21.5 | short neck: between 7 and 10 mm | Ovation | 75.7 | 100 | 1.9 |
Howard DPJ [66] | 2018 | International | 2011–2017 | 1189 | 60 | wide neck: >25 mm | Excluder | 73.9 | 99.9 | 10.4 |
Oliveira NFG [15] | 2018 | International | 2009–2011 | 97 | 48 | wide neck: >30 mm | Endurant | 73.3 | 100 | NA |
Zhou M [67] | 2018 | China | 2010–2015 | 323 | 36 | short neck: <15 mm; very short neck: <10 mm; wide neck: >28 mm; conical neck: neck dilated over 2 mm within 10 mm below; angulated neck: >60 degrees thrombosed neck: the widest part of thrombus (≥2 mm thick) covering at least 50% of the circumference; calcified neck: calcification accounting for more than or equal to 50% of proximal neck | Endurant, Excluder, Zenith | 73 | 89.2 | 10.2 |
Kouvelos GN [68] | 2019 | Greece | 2009–2016 | 64 | 24 | wide neck: 29–32 mm | Endurant | 72.7 | 100 | 1.5 |
McFarland G [69] | 2019 | United States of America | 2000–2016 | 108 | 34.1 | wide neck: >28 mm | Excluder, Zenith, Talent, Endurant, Ovation, AFX | 76.5 | NA | NA |
Sirignano P [70] | 2021 | International | 2017–2018 | 122 | 1 | Anatomy outside IFU for any commercially available endografts, while inside the IFU for the Ovation stent graft | Ovation | 78.65 | 100 | 0 |
First Author | 30 Days | Mean Follow-Up | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Conversion to Open Repair (%) | Reintervention (%) | Migration (%) | Type Ia Endoleak (%) | AAA-Related Mortality (%) | Conversion to Open Repair (%) | Reintervention (%) | Migration (%) | Type Ia Endoleak (%) | AAA-Related Mortality (%) | |
Dillavou ED [24] | 0 | 1.09 | NA | 2.18 | 1.09 | 0 | 8.8 | 0 | 2.18 | 1.09 |
Fairman RM [25] | NA | NA | NA | NA | NA | 3.1 | NA | 13 | 10.5 | NA |
Choke E [26] | 0 | 3 | 0 | 3 | 0 | 0 | 1.5 | 0 | 3 | 0 |
Cox DE [27] | NA | 0 | NA | 0 | NA | NA | 10.5 | 5.26 | 5.26 | NA |
Mc Donnell CO [28] | 0 | 2.17 | 0 | 2.17 | 0 | NA | 0 | 2.17 | 0 | 0 |
Abbruzzese TA [29] | NA | NA | NA | NA | NA | 1.4 | 24 | 1.4 | 0.9 | 11 |
Chisci E [30] | 0 | 0 | 0 | 4.1 | 0 | 2.7 | 20.3 | 2.7 | 5.4 | 4.1 |
Jim J [31] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2.7 | 2.7 | 2.7 |
Troisi N [32] | NA | 1.3 | NA | 1.3 | 1.3 | 0 | 0 | 0 | 0.65 | 0.65 |
Aburahma AF [33] | 0 | 1 | 0 | 1 | 0 | 0 | 7 | 1.3 | 11 | 1 |
Georgiadis GS [34] | NA | NA | NA | NA | NA | 0 | 0 | 0 | 0 | 0 |
Hoshina K [35] | NA | NA | NA | NA | NA | NA | NA | NA | NA | 0 |
Hyhlik-Dürr A [36] | 0 | 2 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
Rouwet EV [37] | 0 | 0 | 0 | 0 | 1.25 | 0 | 0 | 0 | 0 | 1.25 |
Torsello G [38] | 0 | 1.8 | 0 | 3.6 | 0 | 0 | 1.8 | 0 | 3.6 | 1.8 |
Van Keulen JW [39] | 0 | 0 | 0 | 0 | 0 | NA | 0 | NA | 0 | 0 |
Lee M [40] | NA | NA | NA | NA | NA | 0 | 10.5 | 0 | 10.5 | 0 |
Hager ES [41] | 0 | 1.2 | 0 | 7.14 | 0 | 0 | 0 | 0 | 2.4 | 0 |
Kvinlaug KE [42] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Setacci F [43] | 0 | 0 | 0 | 0 | 0 | NA | NA | NA | NA | NA |
Stather PW [44] | NA | 5 | NA | 2.5 | 0.5 | NA | 2.5 | 3 | 9.5 | 2 |
Antoniou GA [45] | NA | NA | NA | NA | NA | 0 | 0 | 0 | 1.7 | 0 |
Mwipatayi BP [46] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Shintan T [47] | NA | NA | NA | NA | NA | 0 | 0 | 25 | 0 | 0 |
Ierardi AM [48] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Igari K [4] | 0 | 0 | 0 | 8 | 0 | 0 | 0 | 0 | 0 | 0 |
Iwakoshi S [49] | 0 | 0 | 0 | 0 | 0 | 0 | 3.14 | 0 | 3.14 | 2.36 |
Setacci F [50] | NA | NA | NA | NA | NA | 0 | 5.5 | 0 | 5.5 | 0 |
Speziale F [7] | 0 | 0 | 0 | 0 | 0 | 0 | 7.7 | 4.6 | 3 | 0 |
Kaladji A [51] | 0 | 8.3 | 0 | 4.1 | 0 | 0 | 24.1 | 0 | 13 | 3.5 |
Saha P [52] | 0 | 0 | 0 | 3.7 | 0 | 0 | 7.4 | 0 | 7.4 | 7.4 |
Cerini P [53] | 2.2 | 11.1 | NA | 8.8 | 0 | 0 | 0 | 0 | 0 | 0 |
de Donato G [54] | 0 | 0 | 0 | 0.6 | 0 | 0 | 1.8 | 0 | 1.8 | 0 |
Gallitto E [55] | NA | 1.5 | NA | 3 | NA | NA | 3 | NA | 1.5 | 3 |
Gimenez-Gaibar A [5] | 0 | 1.9 | 0 | 1.9 | 0 | 0 | 4.5 | 0 | 2.2 | 0 |
Sirignano P [56] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
de Donato G [57] | 0 | 0 | 0 | 0 | 0 | 0 | 2.2 | 0 | 2.2 | 0 |
Gargiulo M [58] | NA | NA | NA | NA | NA | 6 | 7 | 3 | 12 | 3.4 |
Kontopodis N [59] | 1.9 | NA | NA | NA | NA | 0 | 0 | 0 | 0 | NA |
Lee JH [60] | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
Pitoulias GA [61] | 0 | 1.2 | 0 | 1.9 | 0 | 0 | 1.2 | 0 | 1.2 | 0 |
Sirignano P [62] | 0 | 0.7 | 0 | 1.3 | 0 | 0 | 0 | 0 | 0 | 0 |
Reyes Valdiva A [63] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.3 |
Aburahma AF [10] | 0 | 15.2 | 0 | 27.3 | 0 | 0 | 17.2 | 0 | 13.8 | 0 |
Bryce Y [64] | 0 | 1.6 | 0 | 1.6 | 0 | 0.8 | 1.6 | 0 | 1.6 | 0 |
Greaves NS [65] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Howard DPJ [66] | NA | NA | NA | NA | NA | 0.2 | 3 | 0.1 | 0.3 | 0 |
Oliveira NFG [15] | NA | NA | NA | NA | NA | NA | 3.1 | NA | 7.6 | 1 |
Zhou M [67] | NA | NA | NA | NA | NA | NA | 5.6 | NA | 7.1 | NA |
Kouvelos GN [68] | 0 | 0 | 0 | 1.5 | 0 | 7.2 | 10.14 | 2.9 | 4.3 | 1.5 |
McFarland G [69] | NA | NA | NA | NA | NA | 1.85 | 11.1 | 14.8 | 14.8 | 0 |
Sirignano P [70] | 0 | 1.6 | 0 | 1.6 | 0 | NA | NA | NA | NA | NA |
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Sirignano, P.; Ceruti, S.; Aloisi, F.; Sirignano, A.; Picozzi, M.; Taurino, M. Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion. J. Clin. Med. 2022, 11, 4460. https://doi.org/10.3390/jcm11154460
Sirignano P, Ceruti S, Aloisi F, Sirignano A, Picozzi M, Taurino M. Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion. Journal of Clinical Medicine. 2022; 11(15):4460. https://doi.org/10.3390/jcm11154460
Chicago/Turabian StyleSirignano, Pasqualino, Silvia Ceruti, Francesco Aloisi, Ascanio Sirignano, Mario Picozzi, and Maurizio Taurino. 2022. "Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion" Journal of Clinical Medicine 11, no. 15: 4460. https://doi.org/10.3390/jcm11154460
APA StyleSirignano, P., Ceruti, S., Aloisi, F., Sirignano, A., Picozzi, M., & Taurino, M. (2022). Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion. Journal of Clinical Medicine, 11(15), 4460. https://doi.org/10.3390/jcm11154460