Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial Presented in part at the Thirty-ninth Annual Meeting for the Southern Association for Vascular Surgery, Scottsdale, Ariz, January 14-17, 2015.

Mahmoud B. Malas, William D. Jordan, Michol A. Cooper, Umair Qazi, Adam W. Beck, Michael Belkin, William Robinson, Mark Fillinger

Research output: Contribution to journalArticle

Abstract

Objective This study compared the performance of the Aorfix endograft (Lombard Medical, Oxfordshire, United Kingdom) in standard (90°) aortic necks in the PYTHAGORAS study and evaluated changes in neck morphology over time. Methods PYTHAGORAS is a prospective nonrandomized clinical trial of the Aorfix endograft. We divided the endovascular aneurysm repair (EVAR) cohort into groups by standard, high, and severe neck angle. The primary control group was patients concurrently undergoing open repair. Mortality at 30 days, 1 year, and 2 years and 30-day freedom from Society for Vascular Surgery major adverse events for the EVAR groups was compared with the open control. Aneurysm sac change, type I and III endoleaks, graft migration, and the reintervention rate at 1 and 2 years was compared between the standard, highly, and severely angled populations. The relative risk of graft complications with a neck diameter increase >10% was also calculated. At predetermined anatomic points, the effect of oversizing on aortic diameter was evaluated by calculating oversize percentage ([1 - outer aortic diameter measured at a given time/stent graft diameter] × 100%) preoperatively and at 3 years. In addition, the average oversizing percentage at 30 days and annually at 1 to 5 years was compared with the preoperative oversizing percentage. Finally, complication rates with ≥30% vs 10% at 5 mm above the proximal renal and 1 mm below the distal renal, there was an increased risk of graft migration (relative risk, 4.38 [P =.01] and 4.33 [P =.002], respectively). For all predetermined anatomic points, the oversizing percentage decreased over time. The rate of oversize percentage decrease was faster at more distal aortic locations, reaching

Original languageEnglish (US)
Pages (from-to)1108-1118
Number of pages11
JournalJournal of Vascular Surgery
Volume62
Issue number5
DOIs
StatePublished - Nov 1 2015

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Clinical Trials
Aneurysm
Transplants
Neck
Endoleak
Kidney
Stents
Control Groups
Mortality
Population
Non-Randomized Controlled Trials
United Kingdom

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

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Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial Presented in part at the Thirty-ninth Annual Meeting for the Southern Association for Vascular Surgery, Scottsdale, Ariz, January 14-17, 2015. / Malas, Mahmoud B.; Jordan, William D.; Cooper, Michol A.; Qazi, Umair; Beck, Adam W.; Belkin, Michael; Robinson, William; Fillinger, Mark.

In: Journal of Vascular Surgery, Vol. 62, No. 5, 01.11.2015, p. 1108-1118.

Research output: Contribution to journalArticle

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abstract = "Objective This study compared the performance of the Aorfix endograft (Lombard Medical, Oxfordshire, United Kingdom) in standard (90°) aortic necks in the PYTHAGORAS study and evaluated changes in neck morphology over time. Methods PYTHAGORAS is a prospective nonrandomized clinical trial of the Aorfix endograft. We divided the endovascular aneurysm repair (EVAR) cohort into groups by standard, high, and severe neck angle. The primary control group was patients concurrently undergoing open repair. Mortality at 30 days, 1 year, and 2 years and 30-day freedom from Society for Vascular Surgery major adverse events for the EVAR groups was compared with the open control. Aneurysm sac change, type I and III endoleaks, graft migration, and the reintervention rate at 1 and 2 years was compared between the standard, highly, and severely angled populations. The relative risk of graft complications with a neck diameter increase >10{\%} was also calculated. At predetermined anatomic points, the effect of oversizing on aortic diameter was evaluated by calculating oversize percentage ([1 - outer aortic diameter measured at a given time/stent graft diameter] × 100{\%}) preoperatively and at 3 years. In addition, the average oversizing percentage at 30 days and annually at 1 to 5 years was compared with the preoperative oversizing percentage. Finally, complication rates with {\^a}‰¥30{\%} vs 10{\%} at 5 mm above the proximal renal and 1 mm below the distal renal, there was an increased risk of graft migration (relative risk, 4.38 [P =.01] and 4.33 [P =.002], respectively). For all predetermined anatomic points, the oversizing percentage decreased over time. The rate of oversize percentage decrease was faster at more distal aortic locations, reaching",
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AU - Malas, Mahmoud B.

AU - Jordan, William D.

AU - Cooper, Michol A.

AU - Qazi, Umair

AU - Beck, Adam W.

AU - Belkin, Michael

AU - Robinson, William

AU - Fillinger, Mark

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AB - Objective This study compared the performance of the Aorfix endograft (Lombard Medical, Oxfordshire, United Kingdom) in standard (90°) aortic necks in the PYTHAGORAS study and evaluated changes in neck morphology over time. Methods PYTHAGORAS is a prospective nonrandomized clinical trial of the Aorfix endograft. We divided the endovascular aneurysm repair (EVAR) cohort into groups by standard, high, and severe neck angle. The primary control group was patients concurrently undergoing open repair. Mortality at 30 days, 1 year, and 2 years and 30-day freedom from Society for Vascular Surgery major adverse events for the EVAR groups was compared with the open control. Aneurysm sac change, type I and III endoleaks, graft migration, and the reintervention rate at 1 and 2 years was compared between the standard, highly, and severely angled populations. The relative risk of graft complications with a neck diameter increase >10% was also calculated. At predetermined anatomic points, the effect of oversizing on aortic diameter was evaluated by calculating oversize percentage ([1 - outer aortic diameter measured at a given time/stent graft diameter] × 100%) preoperatively and at 3 years. In addition, the average oversizing percentage at 30 days and annually at 1 to 5 years was compared with the preoperative oversizing percentage. Finally, complication rates with ≥30% vs 10% at 5 mm above the proximal renal and 1 mm below the distal renal, there was an increased risk of graft migration (relative risk, 4.38 [P =.01] and 4.33 [P =.002], respectively). For all predetermined anatomic points, the oversizing percentage decreased over time. The rate of oversize percentage decrease was faster at more distal aortic locations, reaching

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