Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms

Gustavo Oderich, Mauricio S. Ribeiro, Giuliano A. Sandri, Emanuel R. Tenorio, Janet M. Hofer, Bernardo C. Mendes, Julia Chini, Stephen Cha

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objective: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs). Methods: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency. Results: There were 145 patients (46%) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54%) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83%) treated in the first half of experience to CMDs in 144 patients (91%) treated in the second half of experience (P <.001). Patients treated by PMEGs had significantly (P <.05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98% vs 99.5%; P =.02). Thirty-day mortality was 5.5% for PMEGs (PRAs, 1.2%; extent IV 3.8% and extent I-III, 17.1%) and 0% for CMDs (P =.0018). Patients treated by PMEGs had significantly more (P <.001) MAEs (48% vs 23%) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P =.001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P <.001). At 3 years, patient survival (68% ± 4% vs 67% ± 8%; P =.11), freedom from reintervention (68% ± 4% vs 68% ± 8%; P =.17), primary (94% ± 2% vs 92% ± 2%; P =.64) and secondary target vessel patency (98% ± 1% vs 98% ± 1%; P =.89), and freedom from renal function deterioration (75% ± 4% vs 65% ± 6%; P =.24) were similar for patients treated by PMEGs or CMDs, respectively. Conclusions: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs.

Original languageEnglish (US)
JournalJournal of Vascular Surgery
DOIs
StateAccepted/In press - Jan 1 2018

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Thoracic Aortic Aneurysm
Aneurysm
Physicians
Equipment and Supplies
Mortality
Comorbidity
Kidney
Mesenteric Arteries
Survival
Renal Artery
Chronic Renal Insufficiency
Lung Diseases

Keywords

  • Company-manufactured device
  • Fenestrated-branched endovascular aortic repair
  • Physician-modified endografts

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. / Oderich, Gustavo; Ribeiro, Mauricio S.; Sandri, Giuliano A.; Tenorio, Emanuel R.; Hofer, Janet M.; Mendes, Bernardo C.; Chini, Julia; Cha, Stephen.

In: Journal of Vascular Surgery, 01.01.2018.

Research output: Contribution to journalArticle

Oderich, Gustavo ; Ribeiro, Mauricio S. ; Sandri, Giuliano A. ; Tenorio, Emanuel R. ; Hofer, Janet M. ; Mendes, Bernardo C. ; Chini, Julia ; Cha, Stephen. / Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. In: Journal of Vascular Surgery. 2018.
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abstract = "Objective: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs). Methods: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency. Results: There were 145 patients (46{\%}) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54{\%}) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83{\%}) treated in the first half of experience to CMDs in 144 patients (91{\%}) treated in the second half of experience (P <.001). Patients treated by PMEGs had significantly (P <.05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98{\%} vs 99.5{\%}; P =.02). Thirty-day mortality was 5.5{\%} for PMEGs (PRAs, 1.2{\%}; extent IV 3.8{\%} and extent I-III, 17.1{\%}) and 0{\%} for CMDs (P =.0018). Patients treated by PMEGs had significantly more (P <.001) MAEs (48{\%} vs 23{\%}) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P =.001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P <.001). At 3 years, patient survival (68{\%} ± 4{\%} vs 67{\%} ± 8{\%}; P =.11), freedom from reintervention (68{\%} ± 4{\%} vs 68{\%} ± 8{\%}; P =.17), primary (94{\%} ± 2{\%} vs 92{\%} ± 2{\%}; P =.64) and secondary target vessel patency (98{\%} ± 1{\%} vs 98{\%} ± 1{\%}; P =.89), and freedom from renal function deterioration (75{\%} ± 4{\%} vs 65{\%} ± 6{\%}; P =.24) were similar for patients treated by PMEGs or CMDs, respectively. Conclusions: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs.",
keywords = "Company-manufactured device, Fenestrated-branched endovascular aortic repair, Physician-modified endografts",
author = "Gustavo Oderich and Ribeiro, {Mauricio S.} and Sandri, {Giuliano A.} and Tenorio, {Emanuel R.} and Hofer, {Janet M.} and Mendes, {Bernardo C.} and Julia Chini and Stephen Cha",
year = "2018",
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day = "1",
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language = "English (US)",
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TY - JOUR

T1 - Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms

AU - Oderich, Gustavo

AU - Ribeiro, Mauricio S.

AU - Sandri, Giuliano A.

AU - Tenorio, Emanuel R.

AU - Hofer, Janet M.

AU - Mendes, Bernardo C.

AU - Chini, Julia

AU - Cha, Stephen

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objective: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs). Methods: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency. Results: There were 145 patients (46%) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54%) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83%) treated in the first half of experience to CMDs in 144 patients (91%) treated in the second half of experience (P <.001). Patients treated by PMEGs had significantly (P <.05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98% vs 99.5%; P =.02). Thirty-day mortality was 5.5% for PMEGs (PRAs, 1.2%; extent IV 3.8% and extent I-III, 17.1%) and 0% for CMDs (P =.0018). Patients treated by PMEGs had significantly more (P <.001) MAEs (48% vs 23%) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P =.001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P <.001). At 3 years, patient survival (68% ± 4% vs 67% ± 8%; P =.11), freedom from reintervention (68% ± 4% vs 68% ± 8%; P =.17), primary (94% ± 2% vs 92% ± 2%; P =.64) and secondary target vessel patency (98% ± 1% vs 98% ± 1%; P =.89), and freedom from renal function deterioration (75% ± 4% vs 65% ± 6%; P =.24) were similar for patients treated by PMEGs or CMDs, respectively. Conclusions: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs.

AB - Objective: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs). Methods: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency. Results: There were 145 patients (46%) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54%) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83%) treated in the first half of experience to CMDs in 144 patients (91%) treated in the second half of experience (P <.001). Patients treated by PMEGs had significantly (P <.05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98% vs 99.5%; P =.02). Thirty-day mortality was 5.5% for PMEGs (PRAs, 1.2%; extent IV 3.8% and extent I-III, 17.1%) and 0% for CMDs (P =.0018). Patients treated by PMEGs had significantly more (P <.001) MAEs (48% vs 23%) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P =.001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P <.001). At 3 years, patient survival (68% ± 4% vs 67% ± 8%; P =.11), freedom from reintervention (68% ± 4% vs 68% ± 8%; P =.17), primary (94% ± 2% vs 92% ± 2%; P =.64) and secondary target vessel patency (98% ± 1% vs 98% ± 1%; P =.89), and freedom from renal function deterioration (75% ± 4% vs 65% ± 6%; P =.24) were similar for patients treated by PMEGs or CMDs, respectively. Conclusions: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs.

KW - Company-manufactured device

KW - Fenestrated-branched endovascular aortic repair

KW - Physician-modified endografts

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