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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1999-2003 2004-2008 2008-2012

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Prostar® XL

Prostar® XL

2007: ProGlide® introduced

ProGlide®

Prostar® XL

Prostar®and ProGlide® are Registered Trademarks of Abbott3

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Literature Review

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89% success in 95 pts.

Single-Center Experiences with PEVAR




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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


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

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Lee et al (2008)*

Smith et al (2009)*


0.7%-2.6% vs 7.4%-20%(8.3% vs 35%1)



5.8 d vs 7.8 d 2.2 vs 4.2 d

Shorter Anesthesia Times


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Lee et al (2008)*

Smith et al (2009)*


0.7%-2.6% vs 7.4%-20%(8.3% vs 35%1)



5.8 d vs 7.8 d 2.2 vs 4.2 d

Less Blood Loss


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Lee et al (2008)*

Smith et al (2009)*


0.7%-2.6% vs 7.4%-20%(8.3% vs 35%1)



5.8 d vs 7.8 d 2.2 vs 4.2 d



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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

19.0

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1999-2003 2004-2008 2008-2012

Ave

rage

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(N)

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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Medical DirectorVascular Surgery

Arizona Heart Hospital



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


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


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


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




Medical Director, Vascular SurgeryArizona Heart Hospital



results from the prospective life registry€¦ · peripheral vascular and endovascular research...

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