Fast-Track Endovascular Aortic Repair
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1 Fast-Track Endovascular Aortic Repair Final Results from the Prospective LIFE Registry Zvonimir Krajcer, MD Texas Heart Institute Houston, TX OVATION Platform
2 Least Invasive Fast-Track EVAR (LIFE) Registry Primary Objective of the LIFE Registry is to demonstrate the clinical and cost benefits associated with the ultra-low profile (14F) Ovation Abdominal Stent Graft platform under the least invasive conditions defined in the Fast-Track EVAR protocol: Percutaneous Access No General Anesthesia No ICU Admission Next-day Discharge
3 LIFE Registry: Study Design Prospective, non-randomized, post-market study 250 patients, up to 40 U.S. centers Independent Clinical Events Committee (CEC) Primary endpoint Major Adverse Event within 30d (10.4% target performance goal) Secondary endpoints Treatment Success (completion of Fast-Track protocol) Procedure, fluoroscopy, and anesthesia time; access complications; ambulatory status; hospital stay; quality of life Freedom from type I/III endoleak; conversion to open repair; rupture; AAA-related reintervention; mortality
4 Investigative Sites and PIs Saint Joseph Hospital Nick Abedi Medical University Of Sc Esrd Joshua Adams Memorial Hospital Of Carbondale Raed Al-Dallow Memorial Hospital Jacksonville Vagar Ali NYU Lutheran Medical Center Enrico Ascher Swedish Medical Center-Cherry Hill Robert Bersin Palomar Medical Center Anatoly Bulkin Syracuse VA Medical Center Michael Costanza Sutter Roseville Medical Center Dmitri Gelfand Sacred Heart Hospital Of Pensacola Stuart Harlin, Huey McDaniel The Heart Hospital Of New Mexico Steve Henao St Luke s Medical Center Richard Heuser Chandler Regional Medical Center Ayman Jamal Southern Ohio Medical Center Thomas Khoury St Luke s Episcopal Hospital Zvonimir Krajcer, Nat l PI Holston Valley Medical Center Chris Metzger Gwinnett Medical Center Charles Moomey John L McClellan Memorial Veterans Mohammed Moursi Middlesex Hospital Bart Muhs TMC Healthcare Matthew Namanny Jersey Shore University Medical Center M. Usman Nasir Kahn Cascade Healthcare Community St Charles Medical Center Bend Wayne Nelson Sutter General Hospital Thomas Park St. Joseph Mercy Oakland Kiritkumar Patel Riverside Methodist Hospital John Phillips West Virginia University Hospitals Lakshmikumar Pillai Naples Community Hospital Downtown Naples Hospital Hiranya Rajasinghe Abrazo Arizona Heart Hospital Venkatesh Ramaiah, Nat l PI Northern Michigan Regional Hospital Jason Ricci Hartford Hospital Parth Shah Bakersfield Heart Hospital Sarabjeet Singh Scottsdale Osborn Medical Center Gavin Slethaug Miriam Hospital Peter Soukas Morton Plant Hospital Douglas Spriggs Temple University Hospital Grayson Wheatley
5 Inclusion Criteria* Patient Selection Infrarenal AAA >5cm, >0.5cm growth in past 6 months, or max diameter >1.5x the transverse adjacent aortic segment Meets indications for use with Ovation Abdominal Stent Graft platform Suitable femoral arteries that allow use of the Perclose ProGlide Suture-Mediated Closure (SMC) System *Abbreviated for Fast-Track related inclusion criteria; full list at clinicaltrials.gov Identifier: NCT
6 Fast-Track Completion Fast-Track attempted in 100% and completed in 87% of patients; Bilateral PEVAR successful in 97% of patients Screened (n=321) Reasons for Screen Failure Anatomic 8 (Unsuitable AAA anatomy for Ovation; small or inadequate access, <5mm) Enrolled (n=250) Other 63 (EVAR contraindicated; planned adjunctive procedures) Yes 87% (n=216) Completed Fast-Track? No 13% (n=34) Reasons for Fast-Track Failure >1 Midnight Stay 20 (Observation of AEs, social issues, etc.) General Anesthesia 6 ICU Admission 11 Cut Down 8 (6 ProGlide failures) Note: Subject may have more than one reason for screen failure, or for moving from Fast-Track protocol
7 Baseline Demographics Patient Demographics Enrolled 250 Age 73 ± 8 Gender Male 83.2% (208) Female 16.8% (42) ASA Grade I 6.0% (15) II 22.8% (57) III 71.2% (178) IV -- Vascular Characteristics Aortic diameter 13 mm from lowest renal artery (mm) 22.8 ± 3.6 Juxtarenal angle (º) 24.1 ± 17.2 Proximal neck length (mm) 24.1 ± 14.9 Sac diameter (mm) 50.6 ± 7.9 Left iliac min access diameter (mm) 7.9 ± 1.9 Right iliac min access diameter (mm) 7.8 ± 1.8
8 In-Hospital Outcomes Fast-Track Group had Faster Procedures and Shorter Recovery Procedural LIFE Fast-Track LIFE Non Fast-Track Access Technical Success (Successful Bilateral PEVAR) PEVAR Cut-Down 100% (216/216) 100% (26/26) 0% (0/8) Blood loss (ml) 59.0 ± ± ± Local/Regional/Conscious Anesthesia 100% (216/216) 85% (22/26) 75% (6/8) Procedure Time (min) 84.2 ± ± ± 35.0 Fluoroscopy time (min) 18.6 ± ± ± 26.5 Recovery Hours to ambulation 7.9 (0.3, 27.8) 15.8 (1.8, 402.2) 15.4 (4.7, 47.7) Hours to normal diet 5.9 (3.5, 12.1) 18.3 (1.6, 390.2) 6.8 (1.8, 19.6) No ICU Admission 100% (216/216) 65% (17/26) 75% (6/8) Hospital Stays / Days 1.2 ± ± ± 0.5 mean ± std / median (min, max) As of August 2, 2016
9 Quality of Life Improvement QOL Change was Highly Significant among Fast-Track Completers p<0.001 n.s. EQ-5D includes a visual analog scale where health is rated from 0 (worst imaginable health) to 100 (best imaginable health) As of August 2, 2016
10 Major Adverse Events No Device-Related or Procedure-Related MAEs 1 MAE non-device nor procedure-related: death due to acute respiratory failure 28 days post procedure As of August 2, 2016
11 Clinical Outcomes Clinical Outcomes LIFE Fast-Track LIFE Non Fast-Track Safety (Treatment Through 30 Days) Freedom from AAA Rupture 100% (216/216) 100% (34/34) Freedom from Conversion to Open Repair 100% (216/216) 100% (34/34) Freedom from AAA-Related Reintervention 100% (216/216) 100% (34/34) Freedom from Mortality 99% (215/216) 100% (34/34) Effectiveness (1 to 40 days)* Freedom from Type I Endoleak 99% (189/190) 100% (27/27) Freedom from Type III Endoleak 100% (190/190) 100% (27/27) As of August 2, 2016 *One month window ranges from 1 to 40 days; results assessed and reported by investigative site
12 Economic Analysis: Fast-Track vs. Standard EVAR PREMIER Control group: 8,306 patients treated with elective infrarenal EVAR at 3,750 U.S. geographically diverse hospitals, academic and community based Analysis is based on inpatient discharge between EVAR without rupture 40-day follow-up to assess re-intervention rate Costs were calculated related to: Access Anesthesia ICU stay Hospital stay The Advisory Board research and analysis, EVAR ICD-9 procedure code 39.71: 50 th percentile tier, 2015 MEDPAR data. Vascular Quality Initiative (VQI): SVS PSO COPI Report 2014, EVAR across VQI centers from Endologix PEVAR Trial: Nelson et al. J Vasc Surg 2014;59:
13 LIFE Fast-Track EVAR is More Cost Effective PREMIER EVAR LIFE FAST-TRACK SAVINGS Anesthesia Access ICU Non-ICU 30 day Reintervention General, 84% Local, 100% $500 $300 $200 Cutdown* Bilateral PEVAR $300 ($900) 1.4 Days, 51% $1,200 0 Days, 0% $15,300 $0 $15, Days 1.2 Days $12,900 $6,700 $6,200 $29.4k, 1.1% 0% $300 $0 $300 TOTAL $29,300 $8,200 $21,100 STANDARD EVAR: Average costs per patient Index anesthesia costs based on all charge master line items related to anesthesia *30% applicability based on anatomic criteria, with 23% bilateral / 7% unilateral PEVAR (Manunga et al, J Vasc Surg, 2013)
14 30d Hospital Readmissions Most common EVAR readmission drivers are MI, renal, respiratory and wound complications Median EVAR readmission cost $17,700 (if for graft occlusion) to $23,600 (if for endoleak) Cost drivers are due to additional surgeries, ICU services, and length of stay LIFE readmission rate is 5x less than contemporary EVAR reports EVAR ACS NSQIP Gupta 2014 EVAR ACS NSQIP Chen 2016 LIFE Registry EVAR Cases (N) Time Period Unplanned 30d Readmission 7.9% 8.1% 1.6% Operation during Readmission 28% - 0% ACS NSQIP: American College of Surgeons National Surgical Quality Improvement Program Chen SL et al. Perioperative Risk Factors for Readmission Following EVAR. Presented at SCVS, Gupta PK, et al. Unplanned readmissions after vascular surgery. J Vasc Surg 2014;59:
15 Conclusions LIFE Registry is the first-ever prospective study to demonstrate safe and effective patient outcomes when utilizing a Fast-Track EVAR protocol: Percutaneous access, no general anesthesia, no ICU admission, and next day discharge No device-related or procedure-related MAEs 100% freedom from rupture, conversion, or secondary interventions Fast-Track EVAR offers significant perioperative cost savings compared to standard EVAR Hospital and ICU stay is main cost driver Low 30d hospital readmission rate Results warrant establishment of Fast-Track Protocol in experienced EVAR centers
16 THANK YOU
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