Journal of Vascular Surgery
Volume 45, Issue 2 , Pages 236-242 , February 2007

Initial results of wireless pressure sensing for endovascular aneurysm repair: The APEX Trial—Acute Pressure Measurement to Confirm Aneurysm Sac EXclusion

Presented at the Society for Vascular Surgery, June 16-19, 2005, Chicago, Ill.

  • Takao Ohki, MD, PhD

      Affiliations

    • Jikei University School of Medicine, Phoenix, Ariz.
    • Dr Ohki has shares in the company.
    • Corresponding Author InformationReprint requests: Takao Ohki, MD, PhD, Department of Vascular Surgery, Jikei University School of Medicine, 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan 105-8461.
  • ,
  • Kenneth Ouriel, MD

      Affiliations

    • Jikei University School of Medicine, Cleveland Clinic Foundation, Tokyo, Japan
  • ,
  • Pierre Galvagni Silveira, MD

      Affiliations

    • Universidade Federal de Santa Catarina, Cleveland, Ohio
  • ,
  • Barry Katzen, MD

      Affiliations

    • Baptist Cardiac and Vascular Institute, Florinapolis, Brazil
  • ,
  • Rodney White, MD

      Affiliations

    • Harbor UCLA Medical Center, Miami, Fla
  • ,
  • Frank Criado, MD

      Affiliations

    • Union Memorial Hospital, Torrance, Calif
  • ,
  • Edward Diethrich, MD

      Affiliations

    • Arizona Heart Institute, Baltimore, Md

Received 25 July 2006 ,Accepted 30 September 2006.

  • Image Result

    The EndoSure sensor. Top: Schematic cross section of the sensor. Bottom: Fabricated sensor. The basket surrounding the sensor has no electrical functionality but acts to keep the sensor centered withi

    The EndoSure sensor. Top: Schematic cross section of the sensor. Bottom: Fabricated sensor. The basket surrounding the sensor has no electrical functionality but acts to keep the sensor centered within the sac. The sensor is approximately 5 mm wide and 30 mm long so as to sample a reasonable fraction of the large volume of the aneurysm sac.

  • Image Result
    External monitor and the antenna.

    External monitor and the antenna.

  • Image Result
    A, The EndoSure sensor delivery sheath with a radiopaque tip marker (R) is introduced over the stiff wire after wire access has been obtained for the main body delivery or after the endograft delivery

    A, The EndoSure sensor delivery sheath with a radiopaque tip marker (R) is introduced over the stiff wire after wire access has been obtained for the main body delivery or after the endograft delivery sheath (D) has been introduced. M, Metal jacket that contains the EndoSure sensor. B, The sensor delivery sheath and the metal jacket are retrieved while the sensor (S) position is maintained with the tether wire. The arrow denotes the radiopaque markers placed at both ends of the EndoSure sensor. C, Once the sensor delivery sheath has been withdrawn, a pigtail catheter is introduced over the existing stiff wire, and angiography is performed for endograft deployment while the sensor (S) is kept inside the sac. Calibration of the sensor and baseline sac pressure measurement with both the angiographic catheter and the sensor are also performed at this time.

  • Image Result
    Correlation of mean sac pressure at the first pressure reading between EndoSure sensor and the angiographic catheter positioned in the aneurysm sac.

    Correlation of mean sac pressure at the first pressure reading between EndoSure sensor and the angiographic catheter positioned in the aneurysm sac.

  • Image Result
    Comparison between sac pulse pressure before and after endovascular aneurysm repair (EVAR). A significant reduction was seen with EVAR (P < .05).

    Comparison between sac pulse pressure before and after endovascular aneurysm repair (EVAR). A significant reduction was seen with EVAR (P < .05).

  • Image Result
    Completion angiogram following EVAR. A: Pre-operative angiogram shows an infra-renal AAA with enough space for the Endograft and the EndoSure Sensor. B: Early phase of the completion angiogram shows a

    Completion angiogram following EVAR. A: Pre-operative angiogram shows an infra-renal AAA with enough space for the Endograft and the EndoSure Sensor. B: Early phase of the completion angiogram shows an Endoleak (E) possibly communicating with the inferior mesenteric artery (I). C: Latter phase angiogram clearly shows the Endoleak (E) and the communication with the inferior mesenteric artery. The entire aneurysm sac was opacified with contrast material. However, the significance and the origin of the Endoleak were not clear.

 Competition of interest: Drs Ohki, Ouriel, Silveira, Katzen, White, Criado, and Diethrich are members of CardioMEMS scientific advisory board and have been compensated for their time.

PII: S0741-5214(06)01843-X

doi: 10.1016/j.jvs.2006.09.060

Journal of Vascular Surgery
Volume 45, Issue 2 , Pages 236-242 , February 2007