Results from the Prospective LIFE Registry€¦ · Peripheral Vascular and Endovascular Research...
Transcript of Results from the Prospective LIFE Registry€¦ · Peripheral Vascular and Endovascular Research...
Results from the Prospective LIFE Registry
“PEVAR is The Way To Go With Small Profile Devices”
Venkatesh Ramaiah, MD, FACS
Medical Director, Vascular SurgeryArizona Heart Hospital
DirectorPeripheral Vascular and Endovascular Research
Arizona Heart Institute
Disclosures
• Speaker name: Venkatesh Ramaiah, MD, FACS
• I have the following potential conflicts of Interest to report:
• Consulting – Endologix Medical Educator
• Employment in industry
• Stockholder of a healthcare company
• Owner of a healthcare company
• Other(s) – National Co-Principal Investigator LIFE Study
• I do not have any potential conflict of interest
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PEVAR was first proposed in 1999…
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Prostar® XL
Prostar® XL
2007: ProGlide® introduced
ProGlide®
Prostar® XL
Prostar®and ProGlide® are Registered Trademarks of Abbott3
MM0421 Rev02
Literature Review
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89% success in 95 pts.
Single-Center Experiences with PEVAR
94% success in 292 pts.
96% success in 500 pts.
96% success in 168 pts.
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Benefit Attribute Study (Year) PEVAR Benefit2
Shorter Procedure Time
Traul et al (2000)§
Howell et al (2002)§
Torsello et al (2003)§
Lee et al (2007)*Morasch et al (2004)§
Bensley et al (2012)*
13 – 77 minutes shorter
Lower In-Room Anesthesia Time Morasch et al (2004)§ 24 minutes shorter
Less Blood LossHowell et al (2002)§
Börner et al (2004)§ 50 – 292 mL less
Fewer Groin Complications
Bensley et al (2012)*
Lee et al (2008)*
Smith et al (2009)*
Al-Khatib et al (2012)*
0.7%-2.6% vs 7.4%-20%(8.3% vs 35%1)
Length of hospital stayJean-Baptiste et al (2007)§
Grenon et al (2009)*
5.8 d vs 7.8 d 2.2 vs 4.2 d
Quicker Procedure Time
§Denotes Prostar®XL as primary SMCD; *Denotes ProGilde® as primary SMCD1Al-Khatib study evaluating only female patients undergoing PEVAR vs. SEVAR2All measurements reported as mean values vs. SEVAR 6
MM0421 Rev02
Benefit Attribute Study (Year) PEVAR Benefit2
Shorter Procedure Time
Traul et al (2000)§
Howell et al (2002)§
Torsello et al (2003)§
Lee et al (2007)*Morasch et al (2004)§
Bensley et al (2012)*
13 – 77 minutes shorter
Lower In-Room Anesthesia Time Morasch et al (2004)§ 24 minutes shorter
Less Blood LossHowell et al (2002)§
Börner et al (2004)§ 50 – 292 mL less
Fewer Groin Complications
Bensley et al (2012)*
Lee et al (2008)*
Smith et al (2009)*
Al-Khatib et al (2012)*
0.7%-2.6% vs 7.4%-20%(8.3% vs 35%1)
Length of hospital stayJean-Baptiste et al (2007)§
Grenon et al (2009)*
5.8 d vs 7.8 d 2.2 vs 4.2 d
Shorter Anesthesia Times
§Denotes Prostar®XL as primary SMCD; *Denotes ProGilde® as primary SMCD1Al-Khatib study evaluating only female patients undergoing PEVAR vs. SEVAR2All measurements reported as mean values vs. SEVAR 7
MM0421 Rev02
Benefit Attribute Study (Year) PEVAR Benefit2
Shorter Procedure Time
Traul et al (2000)§
Howell et al (2002)§
Torsello et al (2003)§
Lee et al (2007)*Morasch et al (2004)§
Bensley et al (2012)*
13 – 77 minutes shorter
Lower In-Room Anesthesia Time Morasch et al (2004)§ 24 minutes shorter
Less Blood LossHowell et al (2002)§
Börner et al (2004)§ 50 – 292 mL less
Fewer Groin Complications
Bensley et al (2012)*
Lee et al (2008)*
Smith et al (2009)*
Al-Khatib et al (2012)*
0.7%-2.6% vs 7.4%-20%(8.3% vs 35%1)
Length of hospital stayJean-Baptiste et al (2007)§
Grenon et al (2009)*
5.8 d vs 7.8 d 2.2 vs 4.2 d
Less Blood Loss
§Denotes Prostar®XL as primary SMCD; *Denotes ProGilde® as primary SMCD1Al-Khatib study evaluating only female patients undergoing PEVAR vs. SEVAR2All measurements reported as mean values vs. SEVAR 8
MM0421 Rev02
Benefit Attribute Study (Year) PEVAR Benefit2
Shorter Procedure Time
Traul et al (2000)§
Howell et al (2002)§
Torsello et al (2003)§
Lee et al (2007)*Morasch et al (2004)§
Bensley et al (2012)*
13 – 77 minutes shorter
Lower In-Room Anesthesia Time Morasch et al (2004)§ 24 minutes shorter
Less Blood LossHowell et al (2002)§
Börner et al (2004)§ 50 – 292 mL less
Fewer Groin Complications
Bensley et al (2012)*
Lee et al (2008)*
Smith et al (2009)*
Al-Khatib et al (2012)*
0.7%-2.6% vs 7.4%-20%(8.3% vs 35%1)
Length of hospital stayJean-Baptiste et al (2007)§
Grenon et al (2009)*
5.8 d vs 7.8 d 2.2 vs 4.2 d
Fewer Groin Complications
§Denotes Prostar®XL as primary SMCD; *Denotes ProGilde® as primary SMCD1Al-Khatib study evaluating only female patients undergoing PEVAR vs. SEVAR2All measurements reported as mean values vs. SEVAR 9
MM0421 Rev02
PEVAR provides benefits across the health care delivery spectrum*
Patient Impact Physician Impact Hospital Impact
Minimally Invasive
Lower general anesthesia time
Less blood loss
Fewer groin complications
Less pain
Quicker recovery time
Quicker procedure time
Improved patient satisfaction
Improved efficiency from quicker procedure time
Patient satisfaction
Lower infection rates
Less need for blood transfusion
Potential for improved OR throughput from quicker procedure times
*As reported in single center publications10
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Effect of Device Profile on Adoption of PEVAR
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1999-2003 2004-2008 2008-2012
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PEVAR Publications Avg. Delivery Sheath Diameter
Source: PubMed (http://www.ncbi.nlm.nih.gov/pubmed/); Manufacturer IFUs
• Growth of PEVAR is complemented by decrease in sheath delivery sizes
• Experience includes both Prostar®XL and ProGlide® SMCDs
Prostar68%
ProGlide29%
PG/PS3%
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Technique Overview• Percutaneous femoral access
– Micropuncture technique
– Ultrasound guidance
– Confirm with arteriogram
– Anterior puncture
• ProGlide Deployment
– Dilate tract w/ 7F sheath
– Advance first ProGlide over 0.035” guidewire
– Remove guidewire
– Advance device until pulsatile bleeding from side port
– Rotate 30o medially, set footplate, and deploy suture
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Procedural Steps: Access
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Procedural Steps: Access
Ultrasound guidance may be helpful
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Procedural Steps: ProGlide Suture Orientation
Crosshair (“10 and 2”)
approach
30o lateral second
“10”30o medial first
“2”
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Procedure Steps: Results
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Results from the Prospective LIFE Registry
“PEVAR is The Way To Go With Small Profile Devices”
Venkatesh Ramaiah, MD, FACS
Medical DirectorVascular Surgery
Arizona Heart Hospital
DirectorPeripheral Vascular and Endovascular Research
Arizona Heart Institute
Persistent EVAR Challenges
Characteristics of Hostile Access Anatomy
• Narrow (<6mm)
• Occluded
• Tortuous
• Calcified
• Aneurysmal
Narrow Access Vessels
Access Vessel
Tortuosity
40% Patients < 6mm*M2S Database – 43,000 CT Scans
3.2 mm5.3
mm
55% Female Patients <6mm**(CHAP) Collaborative effort – 1,063 CT Scans
* Derived from M2S Measurement Database of 43,000 AAA CT Scans
FDA Approved EVAR Devices
Excluder Endologix Endurant Ovation LombardZenith
Additional CE Mark EVAR Devices
Cordis Incraft Bolton Treovance Endologix Nellix
The Ovation System at Arizona Heart
• First experience Feb 8th 2013
• 293 grafts implanted to date
– 100% technical success
• Initial interest in Ovation System:
– Short, challenging necks
– Tight, calcified and tortuous access
The Workhorse SystemVersatility of the Ovation Prime® System in challenging and
straightforward anatomies.
September 2014
Venkatesh G. Ramaiah, MD, FACS; Syed M. Hussain, MD; Jennifer L. Ash, MD; Ayman Jamal, MD; Ravi Hasanadka, MD; and Thomas King, DO
Least Invasive Fast-Track EVAR (LIFE) Registry
• Percutaneous Access• No General Anesthesia• No ICU Admission• Next-day Discharge
Objective: Demonstrate the clinical and cost benefitsassociated with the ultra-low profile (14F) Ovation Abdominal Stent Graft platform under the least invasive conditions defined in the Fast-Track EVAR protocol:
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
• Secondary endpoints– Treatment Success (completion of Fast-Track protocol)
– Procedure, fluoroscopy, and anesthesia time; contrast volume; access complications; ambulatory status; hospital stay; quality of life
– Freedom from type I/III endoleak; conversion to open repair; rupture; AAA-related reintervention; mortality
Saint Joseph HospitalNick Abedi
Medical University Of Sc EsrdJoshua Adams
Memorial Hospital Of CarbondaleRaed Al-Dallow
Memorial Hospital JacksonvilleVagar Ali
NYU Lutheran Medical CenterEnrico Ascher
Swedish Medical Center-Cherry HillRobert Bersin
Palomar Medical CenterAnatoly Bulkin
Syracuse VA Medical CenterMichael Costanza
Sutter Roseville Medical CenterDmitri Gelfand
Chandler Regional Medical CenterAyman Jamal
Southern Ohio Medical CenterThomas Khoury
St Luke’s Episcopal HospitalZvonimir Krajcer, Nat’l PI
Holston Valley Medical CenterChris Metzger
Gwinnett Medical CenterCharles Moomey
John L McClellan Memorial VeteransMohammed Moursi
Middlesex HospitalBart Muhs
TMC HealthcareMatthew Namanny
Jersey Shore University Medical CenterM. Usman Nasir Kahn
Riverside Methodist HospitalJohn Phillips
West Virginia University HospitalsLakshmikumar Pillai
Naples Community Hospital Downtown Naples HospitalHiranya Rajasinghe
Abrazo Arizona Heart HospitalVenkatesh Ramaiah, Nat’l PI
Northern Michigan Regional HospitalJason Ricci
Hartford HospitalParth Shah
Bakersfield Heart HospitalSarabjeet Singh
Scottsdale Osborn Medical CenterGavin Slethaug
Miriam HospitalPeter Soukas
Investigative Sites and PIs
The Heart Hospital Of New MexicoSteve Henao
St Luke’s Medical CenterRichard Heuser
Sacred Heart Hospital Of PensacolaStuart Harlin, Huey McDaniel
Cascade Healthcare Community St Charles Medical Center – BendWayne Nelson
Sutter General HospitalThomas Park
St. Joseph Mercy OaklandKiritkumar Patel
Morton Plant HospitalDouglas Spriggs
Temple University HospitalGrayson Wheatley
Ovation: The Least Invasive Approach
• Lowest profile of any FDA approved EVAR device
• Highly flexible limbs & delivery system
• CustomSeal™ polymer sealing ring conforms to each patient anatomy and protects the neck
Dimensions listed are system outer diameters (OD)
Patient Selection
• Inclusion Criteria*
• 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: NCT02224794
Fast-Track Completion
Fast-Track attempted in 100% and completed in 87% of patients;Bilateral PEVAR successful in 97% of patients
Note: Subject may have more than one reason for screen failure, or for moving from Fast-Track protocol
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
As of August 2, 2016
In-Hospital Outcomes
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 ± 58.4 51.5 ± 41.3 318.8 ± 304.7
Local/Regional/Conscious Anesthesia 100% (216/216) 85% (22/26) 75% (6/8)
Procedure Time (min)† 84.2 ± 27.8 99.5 ± 33.9 145.9 ± 35.0
Fluoroscopy time (min)† 18.6 ± 8.5 20.8 ± 7.3 25.1 ± 26.5
Closure Success 97% (242/250)
Proximal Adjunctive Stenting 3.2% (8/250)
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 ± 0.4 2.9 ± 3.2 1.4 ± 0.5As of August 2, 2016† mean ± std
‡ median (min, max)
Fast-Track Group had Faster Procedures and Shorter Recovery
Quality of Life Improvement
EQ-5D includes a visual analog scale where health is rated from 0 (worst imaginable health) to 100 (best imaginable health)
QOL Change was Highly Significant among Fast-Track Completers
As of August 2, 2016
p<0.001
n.s.
p<0.001
Major Adverse Events
1 MAE non-device nor procedure-related: death due to acute respiratory failure 28 days post procedure
As of August 2, 2016
No Device-Related or Procedure-Related MAEs
LIFE Fast-Track PEVAR EVAR
0.4% (1/250) 0.5% (1/216)1 0% (0/26) 0% (0/8)
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 (One Month)*
Freedom from Type I Endoleak 99% (189/190) 100% (27/27)
Freedom from Type III Endoleak 100% (190/190) 100% (27/27)
*One month window ranges from 1 to 40 days; results assessed and reported by investigative site
As of August 2, 2016
Economic Analysis: Fast-Track vs. Standard EVAR
• Control Group: 8,306 patients treated with elective infrarenalEVAR at a PREMIER facility, an alliance of 3,750 U.S. hospitals• Academic and community-based; OR and Cath Lab/IR Suite
• Analysis is based on EVAR Inpatient Discharge between 2012-2015• EVAR without rupture
• 40-day follow-up to assess reintervention rate
• Costs were calculated related to:• Access
• Anesthesia
• ICU admission
• Hospital stay
ICU
days
(mean)
PREMIERPEVAR Trial
ProGlide
PEVAR
Trial
Cut Down LOS days
(mean)
PREMIERMEDPAR (N=27,737)
SVS VQI(N=11,670)
1.4 1.1 1.5 2.9 2.9 2.2Endologix PEVAR Trial: Nelson et al. J Vasc Surg 2014;59:1181-94 2015 MEDPAR data: The Advisory Board research and analysis, EVAR ICD-9 procedure code 39.71: Vascular Quality Initiative: SVS PSO COPI Report 2014, EVAR across VQI centers from 2011 – 2014.
The Advisory Board research and analysis, EVAR ICD-9 procedure code 39.71: 50th percentile tier, 2015 MEDPAR data. N=26,737.Vascular Quality Initiative (VQI): SVS PSO COPI Report 2014, EVAR across VQI centers from 2011 – 2014. N=11,670.Endologix PEVAR Trial: Nelson et al. J Vasc Surg 2014;59:1181-94
Hospital StayPremier(N=8306)
2015 MEDPAR(N=26,737)
2014 SVS VQI(N=11,670)
LIFE Non Fast-Track
LIFE Fast-Track
Days, mean 2.9 3.3 2.2 1.9 1.2
ICU StayPremier(N=4207)
PEVAR TrialProGlide
(N=50)
PEVAR TrialCut Down
(N=50)
LIFE Non Fast-Track
LIFE Fast-Track
Days, mean 1.4 1.1 1.5 1.2 0
Procedure
Time
Premier OR(N=6261)
Premier Cath Lab IR
(N=586)
2015 MEDPAR (N=26,737)
LIFE Non Fast-Track
(N=34)
LIFE Fast-Track
(N=216)
Minutes, mean 186 206 179 110 82
Benchmarking PREMIER to Other Real-World EVAR Data (e.g. SVS VQI; CMS)
*30% applicability based on anatomic criteria, with 23% bilateral / 7% unilateral PEVAR (Manunga et al, J Vasc Surg, 2013)
AnesthesiaGeneral, 84%
$500 $200Local, 100%
$300
AccessCutdown*
$300($900)
Bilateral PEVAR
$1,200
ICU1.4 Days, 51%
$15,300$15,300
0 Days, 0%
$0
Non-ICU2.3 Days
$12,900$6,200
1.2 Days
$6,700
PREMIER EVAR SAVINGSLIFE
FAST-TRACK
TOTAL $21,100$29,300 $8,200STANDARD EVAR: Average costs per patient
30 dayReintervention
$29.4k, 1.1%
$300$300
0%
$0
Index anesthesia costs based on all charge master line items related to anesthesia
LIFE Fast-Track EVAR is More Cost Effective
30 day Hospital Readmissions
EVARACS NSQIP Gupta 2014
EVARACS NSQIP Chen 2016
LIFE Registry
EVAR Procedures (N) 2369 3886 250
Time Period 2011 2012-2013 2015-2016
30d Readmission - Unplanned 7.9% 8.1% 1.6%
Operation during Readmission 28% n/r 0%
Chen SL et al. Perioperative Risk Factors for Readmission Following EVAR. Presented at SCVS, 2016.
• EVAR readmission drivers: MI, renal, respiratory and wound complications
• Median EVAR readmission cost: $17,700 (if for graft occlusion) to $23,600 (if for endoleak)
• Cost drivers: additional surgeries, ICU services, and length of stay above median
Gupta PK, et al. Unplanned readmissions after vascular surgery. J Vasc Surg 2014;59:473-82.
ACS NSQIP: American College of Surgeons – National Surgical Quality Improvement Program
LIFE readmission rate is 5x less than contemporary EVAR reports
LIFEOvation
IDE
Nellix
Global
Nellix
IDEENGAGE
Endurant
IDE
PEVAR
PGGREAT
Excluder
IDE
Zenith
IDE
Std Risk
N 250 161 277 150 1262 235 50 400 235 200
MAE 0.4% 2.5% 2.9% 2.7% 3.9% 4.0% 4.0% nr na na
death 0.4% 0.6% 1.1% 0.7% 1.3% 0.0% 0.0% 0.5% 1.3% 1.0%
MI 0.0% 1.0% 0.7% 0.0% 1.1% 0.7% 0.0% na na na
stroke 0.0% 0.0% 0.4% 0.0% 0.2% 0.7% 0.0% na na na
renal failure 0.0% 1.0% 0.0% 0.7% 0.3% 0.7% 4.0% na na na
respiratory failure 0.0% 0.6% 0.7% 1.4% 0.0% 1.3% 2.0% na na na
paralysis 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% nr na na na
bowel ischemia 0.0% 0.6% 0.0% 0.7% 0.2% 1.3% 0.0% na na na
blood loss > 1000cc 0.0% 1.0% 0.7% 0.0% 1.4% 0.7% nr na na na
30d Major Adverse Events
Conclusions • First-ever prospective study to demonstrate safe and effective patient outcomes when
utilizing a Fast-Track EVAR protocol:
o 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
• 99% and 100% freedom from type I and type III endoleak
• Fast-Track EVAR offers significant perioperative cost savings compared to standard EVAR
o ICU and Hospital stay are main cost drivers
o Low 30d hospital readmission rate
• Results warrant establishment of Fast-Track Protocol in experienced EVAR centers
Ovation Graft critical part of LIFE Success
Ultra-low profile, highly flexible delivery enables access in 83%1 AAA population
* Patients’ Access Vessel Size Distribution (Derived from M2S Measurement Database of 43,000 CT Scans)
Case Example #1
Images
Anterior Left Posterior Right
Insert “Aortic Diameters” image from DPW (height 2.0 x width 3.5)
Lowest Renal Artery Right Left X
Device Planning Recommendation
Aortic Body
43
Notes
• Vessel dilates between IR+13 and IR+16. Accurate deployment is
essential:
• Adjust for parallax
• Position distal end of RO markers at bottom edge of inferior renal
(left / right) ostium.
• Retract guidewire during polymer fill
• Do not place tension on the aortic body
• Confirm seal; balloon if necessary
• Thrombus in seal zone
• Retract guidewire during polymer fill
• Confirm seal; balloon if necessary
Device Recommendation 29 AB
Min Max Avg.
Device Planning Recommendation
Iliacs
44
Insert “Lengths” image from DPW
(height 1.0 x width 3.5)
Notes
• Confirm limb lengths intra-operatively using a marker catheter
• Narrow native bifurcation:
• Perform kissing balloon technique post limb deployment using
appropriately sized non-compliant balloons if necessary.
Right Left
Device Recommendation 10 x 120 10 x 120
Additional Components
10 x 140
12 x 120
12 x 140
10 x 140
12 x 120
12 x 140
Insert “Iliac Diameters” image from DPW
(height 2.25 x width 3.5)
Anatomical and Procedure Notes
45
Anatomical and Procedure Notes
• Slight stenosis with a calcific
shelf in distal aorta.(IR + 90)
46©2013 TriVascular, Inc. All rights reserved. Caution: Federal (USA) law restricts
this device to sale by or on the order of a physician. 820-0019-01rD
Post Op
• It has significantly reinforced my practice algorithm of treatment of infrarenal AAAs
• Currently perform 96% of all infrarenal AAAs percutaneous (ultrasound assisted)
• ICU stay has almost been eliminated
• Next day discharge has become standard
• This protocol has allowed to partner with the hospital to reduce costs and improve patient satisfaction
How Ovation Fast-Track Protocol Differentiates my Practice
Pick your patients
On-label for bilateral percutaneous and Ovation treatment
Pick your therapy
Ovation and Fast-Track protocol drives predictable cost reduction and clinical outcomes
Life Study
Reinforces most of the techniques, technology and patient selection that allows us to achieve excellent outcomes without compromising patient care, while improving patient satisfaction
Thoughts on Ovation Fast-Track Protocol Utilization
Results from the Prospective LIFE Registry
“PEVAR is The Way To Go With Small Profile Devices”
Venkatesh Ramaiah, MD, FACS
Medical Director, Vascular SurgeryArizona Heart Hospital
DirectorPeripheral Vascular and Endovascular Research
Arizona Heart Institute