Perioperative Outcomes From the Prospective Multicenter Least Invasive Fast-Track EVAR (LIFE) Registry

Author:

Krajcer Zvonimir1,Ramaiah Venkatesh G.2,Henao Esteban A.3,Metzger D. Chris4,Nelson Wayne K.5,Moursi Mohammed M.6,Rajasinghe Hiranya A.7,Al-Dallow Raed8,Miller Larry E.9

Affiliation:

1. CHI St Luke’s Health, Houston, TX, USA

2. Arizona Heart Institute, Phoenix, AZ, USA

3. Heart Hospital of New Mexico, Albuquerque, NM, USA

4. Wellmont CVA Heart Institute, Kingsport, TN, USA

5. Bend Memorial Clinic, Bend, OR, USA

6. Central Arkansas Veterans Healthcare System, Little Rock, AR, USA

7. NCH Healthcare Systems, Naples, FL, USA

8. SIH Memorial Hospital of Carbondale, Carbondale, IL, USA

9. Miller Scientific Consulting, Inc, Asheville, NC, USA

Abstract

Purpose: To determine the feasibility, perioperative resource utilization, and safety of a fast-track endovascular aneurysm repair (EVAR) protocol in well-selected patients. Methods: Between October 2014 and May 2016, the LIFE (Least Invasive Fast-track EVAR) registry ( ClinicalTrials.gov identifier NCT02224794) enrolled 250 patients (mean age 73±8 years; 208 men) in a fast-track EVAR protocol comprised of bilateral percutaneous access using the 14-F Ovation stent-graft, no general anesthesia, no intensive care unit (ICU) admission, and next-day discharge. The primary endpoint was major adverse events (MAE) through 30 days. The target performance goal for the MAE endpoint was 10.4%. Results: Vascular access, stent-graft delivery, and stent-graft deployment success were 100%. A total of 216 (86%) patients completed all elements of the fast-track EVAR protocol. Completion of individual elements was 98% for general anesthesia avoidance, 97% for bilateral percutaneous access, 96% for ICU avoidance, and 92% for next-day discharge. Perioperative outcomes included mean procedure time of 88 minutes, median blood loss of 50 mL, early oral nutrition (median 6 hours), early mobilization (median 8 hours), and short hospitalization (median 26 hours). Fast-track EVAR completers had shorter procedure time (p<0.001), less blood loss (p=0.04), faster return to oral nutrition (p<0.001) and ambulation (p<0.01), and shorter hospital stay (p<0.001). With 241 (96%) of the 250 patients returning for the 30-day follow-up, the MAE incidence was 0.4% (90% CI 0.1% to 1.8%), significantly less than the 10.4% performance goal (p<0.001). No aneurysm rupture, conversion to surgery, or aneurysm-related secondary procedure was reported. There were no type III endoleaks and 1 (0.4%) type I endoleak. Iliac limb occlusion was identified in 2 (0.8%) patients. The 30-day hospital readmission rate was 1.6% overall. Conclusion: A fast-track EVAR protocol was feasible in well-selected patients and resulted in efficient perioperative resource utilization with excellent safety and effectiveness.

Funder

Endologix, Inc.

Publisher

SAGE Publications

Subject

Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging,Surgery

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