Optimizing CO2 Injection Technique for EVAR

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Brief Title

Optimizing CO2 Injection Technique for EVAR

Official Title

Optimizing CO2 Injection Technique for Renal Artery Detection in Endovascular Abdominal Aortic Aneurysm Repair

Brief Summary

      Automated carbon dioxide (CO2) angiography is considered a safe diagnostic alternative to
      standard iodinated contrast medium (ICM) for endovascular aortic repair (EVAR) of abdominal
      aortic aneurysm (AAA), especially in patients with preoperative renal function impairment.

      Recent literature experiences describe the use of automated CO2 angiography in EVAR.

      One of the main issues of CO2 angiography is the inability to detect the origin of the lowest
      renal artery (proximal neck visualization) that was estimated up to 38%.

      In these experiences, the CO2 automated angiography is usually performed by a 5F pigtail
      catheter placed at renal arteries level.

      The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique
      by a 5F introducer (single hole catheter) positioned at the distal level of the proximal neck
      in detecting both renal arteries in the first diagnostic and completion angiographies.
    

Detailed Description

      Endovascular aneurysm repair is currently a wide spread therapeutic option due to a lower
      30-day morbidity/mortality compared with open repair (OR), especially in patients with high
      surgical risk. The routinary EVAR technique requires the use of iodinated contrast medium
      (ICM) which can cause contrast induced-acute kidney injure (CI-AKI). The incidence of CI-AKI
      after EVAR is estimated between 2% and 16% although renal insult can also be caused by
      microembolization, unplanned renal (or polar) artery coverage, renal artery lesion (as
      dissection) or post-operative inflammatory reaction.

      In the past few years, several studies pointed out the importance of reducing the amount of
      iodinated contrast medium injected and proposed carbon dioxide (CO2) as an alternative to
      partially or completely replace ICM, especially in patients with preoperative chronic renal
      impairment.

      According with the literature, manual or automatic CO2 injection provides a good quality
      imaging of both proximal and distal sealing zone in standard EVAR procedures and, combined
      with fusion imaging, allows to perform juxta and pararenal abdominal aortic aneurysm repair
      with fenestrated endograft reducing the total amount of ICM required to the procedure.

      The most relevant limit to the use of CO2 is the inability to identify the proximal landing
      zone and the lowest renal artery that occurs in a significant number of cases (38.7%).

      This limit could be related to the physical property of CO2 because, differently from ICM, it
      is a gas that does not completely fill the aortic lumen but it floats in the anterior portion
      of the aneurysmatic sac and does not allow the detection of renal arteries with a posterior
      origin.

      The automated CO2 injection is commonly performed using a pigtail catheter (5F/65mm length)
      placed at the renal arteries level.

      The primary end point of the study is to identify an alternative and effective method of CO2
      injection, using an automatic system through the digital Angiodroid injection system
      (Angiodroid Srl, San Lazzaro, Bologna) connected to a 5F introducer placed at the distal
      portion of infra-renal neck that allows the identification of the lowest renal artery.

      This is a prospective, single center, observational, case-control study, in which each
      patient is the control of himself because during the procedure 2 angiographic CO2 techniques
      (angiography by pig tail vs 5 F introducer) are performed and compared.

      All patients underwent a preoperative computed tomography angiography (CTA) within 3 months
      before the procedure. The images are analyzed using a dedicated software for vessel analysis
      (3Mensio TM, Vascular Imaging Bilthover, Netherlands) and the AAA volume is calculated using
      the same software by selecting points of the external aortic wall and internal aortic lumen
      from the lower renal artery to the aortic bifurcation.

      The level of renal arteries and aortic bifurcation are evaluated on preoperative CTA
      reconstructions and matched with vertebral bone landmarks.

      At the beginning of the procedure two CO2 DSA will be performed: the first one through the
      pigtail placed at the level of renal arteries and the second one through a 5F introducer
      placed at the end of the proximal sealing zone in order to identify the lowest renal artery
      and compare the quality of the images obtained.

      The same way, at the end of the procedure after the endograft deployment, two CO2 DSA will be
      performed: the first one through the pigtail catheter placed at the level of renal arteries
      and the second one through the 5F introducer placed at the level of the contralateral iliac
      limb.

      The investigators prospectively collect clinical and morphological preoperative,
      intraoperative and postoperative data as shown in the table above.

      Clinical characteristics: age years, sex, hypertension (systolic blood pressure ≥140 or/and
      diastolic ≥90 mmHg, or specific therapy), dyslipidemia (total cholesterol ≥200 mg/dl or low
      density lipoprotein ≥120 mg/dl or specific therapy), diabetes mellitus (pre-diagnosed in
      therapy with oral hypoglycemic drugs or with insulin), current smoking, coronary artery
      disease (defined as a history of angina pectoris, myocardial infarction or coronary
      revascularization), chronic obstructive pulmonary disease (defined as chronic bronchitis or
      emphysema), chronic kidney disease (glomerular filtration rate <60 ml/min), dialysis, pre and
      post-operative creatinine serum, ASA (American Society Anesthesiologic classification),
      medical therapy (antiplatelet types, anticoagulant therapy, statin therapy, anti-hypertensive
      medical therapy).

      Morphological characteristics: aneurysm diameter, aneurysm volume, aneurysm neck features
      according to Chaickof classification, iliac axes features according to Chaickof
      classification, renal arteries number and clock position, hypogastric arteries patency,
      aortic carrefour diameter.

      Intraoperative data: anesthesia (general or spinal), vascular access (surgical or
      percutaneous), endograft features (bi- or tri-modular, suprarenal fixation, proximal diameter
      of the endograft, left and right iliac limb diameter, embolization of the aneurysmatic sac,
      coils number, hypogastric embolization or coverage, other adjunctive maneuvers as iliac axes
      stenting), type and amount of contrast medium, fluoroscopy time, dose area product (DAP)
      (fluoroscopy DAP, DSA DAP and total DAP), renal arteries detection at the beginning of the
      procedure with CO2 DSA from 5F pigtail and 5F introducer, renal and hypogastric arteries and
      endoleaks detection at the end of the procedure with CO2 DSA from 5F pigtail and 5F
      introducer (as explained before).

      Post-operative data: complications related to CO2 injection rate (nausea, vomit, abdominal
      pain, hypotension), endoleaks at the discharge, perioperative mortality, 30-days mortality,
      30-days medical or surgical complications, 30-days reintervention rate, 30-days renal
      function.
    


Study Type

Observational


Primary Outcome

Aortic neck detection

Secondary Outcome

 CO2 complications

Condition

Abdominal Aortic Aneurysm

Intervention

Technique 1

Study Arms / Comparison Groups

 Population
Description:  The group includes all patients undergoing EVAR, each patient is considered as both case and control of himself as the two CO2 injection techniques, through the 5F pigtail and through the 5F introducer, are both used during the procedure.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

30

Start Date

January 1, 2021

Completion Date

September 15, 2022

Primary Completion Date

June 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with asymptomatic infrarenal abdominal aortic aneurysm admitted to the S.
             Orsola - Malpighi Hospital for a planned EVAR procedure. All patients underwent a
             preoperative computed tomography angiography (CTA) with a <2mm slices.

        Exclusion Criteria:

          -  Patients with contraindication for CO2 (cardiac septal defects, pulmonary
             arteriovenous malformations, pulmonary hypertension, severe emphysema)

          -  Patients requiring advanced aortic repair (FEVAR, BEVAR)

          -  Urgent cases
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Enrico Gallitto, MD, PhD, +390512143288, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT05304026

Organization ID

CO2 IT


Responsible Party

Principal Investigator

Study Sponsor

University of Bologna


Study Sponsor

Enrico Gallitto, MD, PhD, Principal Investigator, University of Bologna


Verification Date

March 2022