Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft

Gianmarco De Donato, Francesco Setacci, Luciano Bresadola, Patrizio Castelli, Roberto Chiesa, Nicola Mangialardi, Giovanni Nano, Carlo Setacci, Carmelo Ricci, Daniele Gasparini, Gianluca Piccoli, Andrea Kahlberg, Silvia Stegher, Gianpaolo Carrafiello, Nicola Rivolta, Claudio Novali, Carlo Rivellini, Massimo Lenti, Giacomo Isernia, Sonia Ronkey & 8 others Rocco Giudice, Francesco Speziale, Pasqualino Sirignano, Giustino Marcucci, Federico Accrocca, Pietro Volpe, Francesco Talarico, Gaetano La Barbera

Research output: Contribution to journalArticle

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Abstract

Objective Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. Methods This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. Results Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P =.05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). Conclusions No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.

Original languageEnglish
Pages (from-to)8-15
Number of pages8
JournalJournal of Vascular Surgery
Volume63
Issue number1
DOIs
Publication statusPublished - Jan 1 2016

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Stents
Aneurysm
Transplants
Neck
Endoleak
Aorta
Tomography
Renal Artery
Dilatation
Polymers
Superior Mesenteric Artery
Abdominal Aortic Aneurysm
Abdomen
Registries
Rupture
Thrombosis
Software
Arteries
Equipment and Supplies
Infection

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

De Donato, G., Setacci, F., Bresadola, L., Castelli, P., Chiesa, R., Mangialardi, N., ... La Barbera, G. (2016). Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft. Journal of Vascular Surgery, 63(1), 8-15. https://doi.org/10.1016/j.jvs.2015.07.099

Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft. / De Donato, Gianmarco; Setacci, Francesco; Bresadola, Luciano; Castelli, Patrizio; Chiesa, Roberto; Mangialardi, Nicola; Nano, Giovanni; Setacci, Carlo; Ricci, Carmelo; Gasparini, Daniele; Piccoli, Gianluca; Kahlberg, Andrea; Stegher, Silvia; Carrafiello, Gianpaolo; Rivolta, Nicola; Novali, Claudio; Rivellini, Carlo; Lenti, Massimo; Isernia, Giacomo; Ronkey, Sonia; Giudice, Rocco; Speziale, Francesco; Sirignano, Pasqualino; Marcucci, Giustino; Accrocca, Federico; Volpe, Pietro; Talarico, Francesco; La Barbera, Gaetano.

In: Journal of Vascular Surgery, Vol. 63, No. 1, 01.01.2016, p. 8-15.

Research output: Contribution to journalArticle

De Donato, G, Setacci, F, Bresadola, L, Castelli, P, Chiesa, R, Mangialardi, N, Nano, G, Setacci, C, Ricci, C, Gasparini, D, Piccoli, G, Kahlberg, A, Stegher, S, Carrafiello, G, Rivolta, N, Novali, C, Rivellini, C, Lenti, M, Isernia, G, Ronkey, S, Giudice, R, Speziale, F, Sirignano, P, Marcucci, G, Accrocca, F, Volpe, P, Talarico, F & La Barbera, G 2016, 'Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft', Journal of Vascular Surgery, vol. 63, no. 1, pp. 8-15. https://doi.org/10.1016/j.jvs.2015.07.099
De Donato, Gianmarco ; Setacci, Francesco ; Bresadola, Luciano ; Castelli, Patrizio ; Chiesa, Roberto ; Mangialardi, Nicola ; Nano, Giovanni ; Setacci, Carlo ; Ricci, Carmelo ; Gasparini, Daniele ; Piccoli, Gianluca ; Kahlberg, Andrea ; Stegher, Silvia ; Carrafiello, Gianpaolo ; Rivolta, Nicola ; Novali, Claudio ; Rivellini, Carlo ; Lenti, Massimo ; Isernia, Giacomo ; Ronkey, Sonia ; Giudice, Rocco ; Speziale, Francesco ; Sirignano, Pasqualino ; Marcucci, Giustino ; Accrocca, Federico ; Volpe, Pietro ; Talarico, Francesco ; La Barbera, Gaetano. / Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft. In: Journal of Vascular Surgery. 2016 ; Vol. 63, No. 1. pp. 8-15.
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abstract = "Objective Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. Methods This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. Results Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92{\%} male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1{\%} (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100{\%}. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100{\%}. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P =.05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). Conclusions No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.",
author = "{De Donato}, Gianmarco and Francesco Setacci and Luciano Bresadola and Patrizio Castelli and Roberto Chiesa and Nicola Mangialardi and Giovanni Nano and Carlo Setacci and Carmelo Ricci and Daniele Gasparini and Gianluca Piccoli and Andrea Kahlberg and Silvia Stegher and Gianpaolo Carrafiello and Nicola Rivolta and Claudio Novali and Carlo Rivellini and Massimo Lenti and Giacomo Isernia and Sonia Ronkey and Rocco Giudice and Francesco Speziale and Pasqualino Sirignano and Giustino Marcucci and Federico Accrocca and Pietro Volpe and Francesco Talarico and {La Barbera}, Gaetano",
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T1 - Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft

AU - De Donato, Gianmarco

AU - Setacci, Francesco

AU - Bresadola, Luciano

AU - Castelli, Patrizio

AU - Chiesa, Roberto

AU - Mangialardi, Nicola

AU - Nano, Giovanni

AU - Setacci, Carlo

AU - Ricci, Carmelo

AU - Gasparini, Daniele

AU - Piccoli, Gianluca

AU - Kahlberg, Andrea

AU - Stegher, Silvia

AU - Carrafiello, Gianpaolo

AU - Rivolta, Nicola

AU - Novali, Claudio

AU - Rivellini, Carlo

AU - Lenti, Massimo

AU - Isernia, Giacomo

AU - Ronkey, Sonia

AU - Giudice, Rocco

AU - Speziale, Francesco

AU - Sirignano, Pasqualino

AU - Marcucci, Giustino

AU - Accrocca, Federico

AU - Volpe, Pietro

AU - Talarico, Francesco

AU - La Barbera, Gaetano

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Objective Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. Methods This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. Results Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P =.05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). Conclusions No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.

AB - Objective Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. Methods This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. Results Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P =.05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). Conclusions No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.

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