Initial results of wireless pressure sensing for endovascular aneurysm repair: the APEX Trial--Acute Pressure Measurement to Confirm Aneurysm Sac EXclusion.
OBJECTIVE
Complete exclusion and depressurization of the aneurysm sac is the prime goal of endovascular repair (EVAR) of abdominal aortic aneurysms. Thus, any EVAR that results in a type I or III endoleak has been classified as a technical failure. The current method to detect endoleaks uses intraoperative aortography. However, aortography is limited by its subjective nature, inability to quantify the significance of the endoleak, and artifacts such as bowel gas that may mimic an endoleak. In addition, repetitive contrast injection may impair renal function. To increase the efficacy and safety of intraoperative endoleak detection, a wireless pressure-monitoring system has been developed and tested in the clinical setting.


METHODS
The APEX trial (Acute Pressure Measurement to Confirm Aneurysm Sac EXclusion) is a prospective, multicenter/international trial sponsored by CardioMEMS to evaluate the safety and efficacy of the EndoSure wireless pressure sensor for EVAR. The 30 x 5 x 1.5-mm sensor contains no battery and is powered externally with radiofrequency energy. The sensors are extremely stable, operate over the full physiologic range of pressures, and have a resolution of 1 mm Hg. A total of 90 patients were enrolled at 12 sites, 76 of whom were eligible for analysis. The sensor was implanted via the contralateral femoral artery at the time of EVAR. The sac pulse pressure was measured with both an angiographic catheter and the sensor after deployment of the main endograft but before the deployment of the contralateral limb (type I endoleak equivalent). Sac pressure was again measured with the sensor after deployment of the contralateral limb and completion of the EVAR. Data were collected in a prospective manner.


RESULTS
In all of the eligible patients (n = 76), the initial sensor pressure measurement agreed closely with the angiographic catheter pressure measurement of the type I endoleak equivalent. At the completion of the procedure, there was agreement between the sensor measurement and angiography regarding the presence or absence of a type I or III endoleak in 92.1% (n = 70) of the measurements. Overall, the sensitivity was 0.94 and the specificity was 0.80 for detecting type I or III endoleaks. Final pulse pressures decreased significantly compared with baseline measurements.


CONCLUSIONS
Implantation of the wireless pressure sensor is safe, and remote aneurysm sac pressure sensing is feasible. It was a valuable guide in evaluating the completeness of the EVAR procedure. Long-term study will be needed to prove its efficacy for postoperative surveillance.
Ohki
Takao
T
Department of Vascular Surgery, Jikei University School of Medicine, Tokyo, Japan. takohki@msn.com
Ouriel
Kenneth
K
Silveira
Pierre Galvagni
PG
Katzen
Barry
B
White
Rodney
R
Criado
Frank
F
Diethrich
Edward
E
D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001794:Blood Pressure; D015924:Blood Pressure Monitors; D004867:Equipment Design; D005260:Female; D006801:Humans; D007430:Intraoperative Care / Q000295:instrumentation / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D015641:Radiography, Interventional; D012680:Sensitivity and Specificity; D015607:Stents; D014160:Transducers, Pressure