Perioperative Hypotension and Survival After Elective AAA Repair

NCT07511101 | Completed

• 1 other identifier: 2023-2187
• Study Type: observational
• Target: 511
• Locations: 1 country
• Sites: 1

Brief Summary

Background: An abdominal aortic aneurysm (AAA) is a localized dilatation of the infrarenal aorta that, when it meets critical criteria, can rupture and cause a vital emergency, requiring immediate surgery with a mortality rate close to 85%(1). Also, symptomatic AAA and/or imminent rupture is a surgical emergency that should be recognized and treated promptly. Elective procedures are usually performed in patients with AAA with a diameter greater than 5.5 cm in men and 5.0 cm in women(2,3). There are different techniques for the surgical repair of AAA, which are divided into two main groups: endovascular and open procedures. The endovascular procedure offers an early survival benefit, better postoperative recovery, and fewer incision-related complications as it is a minimally invasive procedure. However, it requires more re-interventions, but most are mainly minor endovascular procedures. In contrast, an open approach has a better 15-year late survival benefit, associated with greater graft durability, a lower rate of re-interventions, and the additional advantage of being more affordable (4-7). Several risk factors have been established around surgical procedures that may affect the outcome, including preoperative and intraoperative hypotension. Preoperative hypotension is one of the most crucial factors, especially when talking about ruptured AAA, where it is present with a high frequency and has been seen as an association with mortality with an AOR of 3.28 (CI 1.75-5.41; P \< .001) (8). For intraoperative hypotension, a study showed that it increased the 30-day mortality after an elective open repair of AAA with an OR of 6.61 (CI 0.71-61.07; p = 0.05). Also, it has been associated with liver dysfunction (p \< 0.001) and colonic ischemia (P=0.021) (9-11). However, the frequency and effects of postoperative hypotension in open and endovascular AAA surgery have not been described in the literature despite the everyday use of vasopressor medications (48%) in the immediate medical management following an open AAA repair(12). However, other studies have shown that postoperative hypotension in abdominal surgery is a significant complication that can have adverse effects on the patient. This condition is characterized by a decrease in blood pressure, which can lead to myocardial injury, acute kidney damage, and an increase in short-term mortality(13). According to literature, postoperative hypotension is common after major abdominal surgeries, and its detection may be suboptimal if routine vital sign assessments are the sole monitoring method. A prospective observational study found that nearly one-quarter of patients experienced episodes of mean arterial pressure (MAP) below 70 mmHg for at least 30 minutes, many of which went undetected through routine evaluations(14). Another study highlighted that prolonged postoperative hypotension, defined by absolute MAP thresholds, is associated with myocardial injury, especially when MAP falls below 65 mmHg for extended periods (15). In addition, in other vascular interventions like carotid endarterectomy, postoperative hypotension has been associated with increased risks of 30-day mortality, stroke, myocardial infarction, and length of stay(16). Given the potential implications for adverse perioperative outcomes, it is essential to elucidate potential risk factors to tailor the perioperative management of AAA repair further. Thus, we aim to describe the mortality and determine the risk factors associated with peroperative and postoperative hypotension at 48 hours in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 1-1-2013 until 31-12-2021. Research question: What were the risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 to 2021? Hypothesis: Alternate hypothesis: There are specific risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 until 2021.

Conditions

AAA - Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; Intraoperative Hypotension; Postoperative Hypotension; Endovascular Aneurysm Repair; Open Aneurysm Repair

Outcome Measures

Primary Outcomes (1)

• 30-day survival

  30-day survival

  30 days

Secondary Outcomes (3)

• 1-year survival

  1-year

• Prevalence intra-operative hypotension

  peri-operative

• Prevalence post-operative hypotension

  until 48 hours post-operatively

Study Arms (2)

non-complex AAA repair

Patients treated with standard EVAR

Complex AAA repair

Patients treated by complex endovascular or open AAA repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an abdominal aortic aneurysm treated electively between 2013 and 2022.

You may qualify if:

• Age \> 18 years
• Elective AAA repair between 2013 and 2022 (endovascular and open)

You may not qualify if:

• Data from the blood pressure monitoring system were only available from 2013, so patients treated before January 1th 2013 were excluded.
• Patients were also excluded from the study if registered objection to use their data for research,
• absence of blood pressure data,
• revision surgery after previous endovascular or open repair,
• ruptured aneurysm,
• mycotic aneurysm, or
• treatment with endovascular aneurysm sealing.

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate

Arnhem, Gelderland, 6515AD, Netherlands

Location

Related Publications (1)

• References: 1. Pereira BMT, Chiara O, Ramponi F, Weber DG, Cimbanassi S, De Simone B, et al. WSES position paper on vascular emergency surgery. World J Emerg Surg. 2015 Dec;10(1):49. 2. Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, et al. Abdominal aortic aneurysms. Nat Rev Dis Primer. 2018 Dec;4(1):34. 3. Carino D, Sarac T, Ziganshin B, Elefteriades J. Abdominal Aortic Aneurysm: Evolving Controversies and Uncertainties. Int J Angiol. 2018 Jun;27(02):058-80. 4. van Schaik TG, Yeung KK, Verhagen HJ, de Bruin JL, van Sambeek MRHM, Balm R, et al. Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2017 Nov;66(5):1379-89. 5. Lederle FA. Outcomes Following Endovascular vs Open Repair of Abdominal Aortic AneurysmA Randomized Trial. JAMA. 2009 Oct 14;302(14):1535. 6. Veith FJ, Lachat M, Mayer D, Malina M, Holst J, Mehta M, et al. Collected World and Single Center Experience With Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms. Ann Surg. 2009 Nov;250(5):818-24. 7. Patel R, Sweeting MJ, Powell JT, Greenhalgh RM. Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial. The Lancet. 2016 Nov;388(10058):2366-74. 8. Latz CA, Boitano L, Schwartz S, Swerdlow N, Dansey K, Varkevisser RRB, et al. Contemporary mortality after emergent open repair of complex abdominal aortic aneurysms. J Vasc Surg. 2021 Jan;73(1):39-47.e1. 9. Sprung J, Levy PJ, Tabares AH, Gottlieb A, Schoenwald PK, Olin JW. Ischemic liver dysfunction after elective repair of infrarenal aortic aneurysm: Incidence and outcome. J Cardiothorac Vasc Anesth. 1998 Oct;12(5):507-11. 10. Davidovic LB, Maksic M, Koncar I, Ilic N, Dragas M, Fatic N, et al. Open Repair of AAA in a High Volume Center. World J Surg. 2017 Mar;41(3):884-91. 11. Ilic N, Zlatanovic P, Koncar I, Dragas M, Muta

  BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 6, 2026
• Study Start: January 17, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

NL (1)