Community Hospital Experience Utilizing the Least Invasive Fast-Track Protocol: Implementation, Challenges, and Results

Transcription

1 Community Hospital Experience Utilizing the Least Invasive Fast-Track Protocol: Implementation, Challenges, and Results HA Rajasinghe MD The Vascular Group of Naples Naples, Florida

2 Financial Disclosures None 2

3 Better medicine = Better economics Allen Weiss MD, circa 2002 NCH Physician s Lounge

4 Traditional EVAR WHILE EVAR IS BECOMING INCREASINGLY PREFERRED OVER OPEN SURGICAL REPAIR, OPPORTUNITIES FOR IMPROVEMENT STILL EXIST Patients underserved due to EVAR ineligibility Longer than desired hospital and ICU stays General Anesthesia 30 day Readmissions MISSED REVENUE INCREASED COSTS

5 Fast-Track EVAR Concept is Feasible Risk Appropriate: In-hospital mortality following 132,000 elective EVAR at 1207 hospitals is low (0.7%) 2 Fast-Track care being adopted for elective open infrarenal AAA repair with shorter ICU and hospital stays and reduced mortality 1 Bilateral PEVAR and Local Anesthesia: Largest PEVAR study (n=915) reports 94% treatment success, 1.3 day mean hospital stay, and 0.6% 30-day mortality 3 Short Stay EVAR: Patients can achieve early discharge if an established protocol is in place 4 1. Hicks et al. JAMA Surg. E-Pub May 18, 2016 / 2. Muehling et al. ICTS. 2011;12: Krajcer et al. J Cardiovasc Surg. 2012;53: / 4. Al-Kuhir et al. EJVES. 2012;43:

6 Premise of Fast-Track EVAR Traditional EVAR Femoral artery exposure 1, 2 General anesthesia 1 ICU stay 3 2 to 3 day LOS 4,5 increases perioperative morbidity and contributes to overall cost of EVAR FAST-TRACK EVAR Percutaneous access No general anesthesia No ICU time Next-day discharge improves patient outcomes, patient satisfaction, and healthcare resource utilization 1. Lederle et al. JAMA 2009;32(14): Manunga et al. J Vasc Surg 2013;58(5): Mayo Clinic Study of PEVAR; 30% applicability based on anatomic criteria, with 23% bilateral / 7% unilateral PEVAR 3. The Endologix PEVAR Trial, Mean ICU Stay 1.3 (ProGlide) and 1,8 (Cutdown) days: Nelson et al. J Vasc Surg 2014;59: The Advisory Board research and analysis, EVAR ICD-9 procedure code 39.71: 50 th percentile tier, 2015 MEDPAR data 5. Vascular Quality Initiative (VQI): SVS PSO COPI Report 2014, EVAR across VQI centers from

7 Least Invasive Fast-Track (LIFE) EVAR Registry Objective: 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 7

8 Ovation: The Least Invasive Approach Low profile 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) 8

9 LIFE : 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 MM1564 Rev

10 Investigative Sites and PIs St Luke s Episcopal Hospital Zvonimir Krajcer, Nat l PI Abrazo Arizona Heart Hospital Venkatesh Ramaiah, Nat l PI 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 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 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

11 FAST-TRACK COMPLETION Fast-Track attempted in 100% and completed in 87% of patients; Bilateral PEVAR successful in 97% of patients Screened (n=321) Enrolled (n=250) Reasons for Screen Failure Anatomic Other 8 (Unsuitable AAA anatomy for Ovation; small or inadequate access, <5mm) 63 (EVAR contraindicated; planned adjunctive procedures) Yes (n=216) Completed Fast-Track? No (n=34) Reasons for Fast-Track Failure >1 Midnight Stay General Anesthesia 20 (Observation of AEs, social issues, etc.) ICU Admission 11 Cut Down 6 8 (6 ProGlide failures) Note: Subject may have more than one reason for screen failure, or for moving from Fast-Track protocol

12 Clinical Outcomes: Primary Endpoints Clinical Outcomes Safety (Treatment Through 30 Days) Fast-Track Completers Fast-Track Non-Completers 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) *One month window ranges from 1 to 40 days; results assessed and reported by investigative site As of August 2, 2016 MM1564 Rev 01

13 No Device- or Procedure-Related MAEs LIFE Fast-Track PEVAR EVAR 0.4% (1/250) 0.5% (1/216) 1 0% (0/26) 0% (0/8) 1 MAE non-device nor procedure-related: death due to acute respiratory failure 28 days post procedure As of August 2, 2016

14 Fast-Track EVAR: Lowest Reported 30d MAE Rate across EVAR Studies LIFE Fast-Track Ovation IDE Nellix Global Nellix IDE ENGAGE Endurant IDE PEVAR Trial ProGlide GREAT Excluder IDE Zenith IDE Std Risk N 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% 30d MAEs for EVAR commercially available devices shown per the respective US FDA Summary of Safety and Effectiveness Data (SSED) and peer-reviewed publications of trial results. Endologix PEVAR Trial: Nelson et al. J Vasc Surg 2014;59: ; Nellix Global Registry: Thompson et al, J Endovasc Ther 2016; ENGAGE Registry: Stokmans et al, Eur J Vasc Endovasc Surg 2012; 44: ; GREAT Registry: Verhoeven et al, Eur J Vasc Endovasc Surg 2014; 48(2): MM1564 Rev 01

15 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 EVAR Nat l Vasc Registy 2016 LIFE Registry EVAR Cases (N) Time Period Unplanned 30d Readmission 7.9% 8.1% 6.0% 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: National Vascular Registry. 2015

16 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

17 In-Hospital Outcomes Fast-Track Completers had Faster Recovery Recovery Fast-Track Completion (n=216) PEVAR Fast-Track Non-Completion (n=34) Cut-Down 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 MM1564 Rev 01

18 Cost Effectiveness of Fast-Track EVAR Control Group: Traditional EVAR = elective infrarenal EVAR performed 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 EVAR without rupture 40-day follow-up to assess reintervention rate EVAR Costs were calculated related to: Access ICU admission Hospital stay Unplanned Readmission Unplanned Reintervention Source: Procedure time, ICU stay, ward stay, MAE, and secondary procedure data obtained from PREMIER, MAE cost reported as weighted average of four adverse events; anesthesia cost assumed identical among types; incremental cost of bilateral PEVAR calculated as $800 for closure devices minus $500 for non-use of cutdown tray/sutures. 30-day readmission cost for other reasons estimated from literature..

19 Cost Effectiveness of Fast-Track EVAR 30-day results LIFE Registry FAST-TRACK EVAR Traditional EVAR Cost Savings Procedure Time min $1,725 Bilateral PEVAR 100% 35% ($195) ICU days $1,388 LOS days $1,273 Readmission for MAE 0.5% 7.7% $1,331 Readmission for Reintervention 0.0% 3.0% $902 Readmission for Other Reason 1.1% 3.0% $190 Average cost savings per patient $6,614

20 Overall, good clinical judgment and a good level of experience as an implanter is required.

21 VOLUME/EXPERIENCE HOSPITAL VOLUME 25 to 50 EVAR cases per year PHYSICAN EXPERIENCE Credentialed to perform percutaneous EVAR using large-hole closure devices. Minimum 10 successful PEVAR cases performed without conversion to open femoral cut-down.

22 KEYS TO SUCCESS: ENDOVASCULAR SPECIALIST Leadership skills amongst peers and good relationships with hospital administration Passion for innovation in their practice Desire to improve patient care with early discharge and high satisfaction, with secondary benefits of cost savings across the system. Focused on patient s best interest Experienced in EVAR Understands marketing advantage and practice building

23 FAST TRACK TEAM FOR SUCCESS Endovascular Team Nursing Support Patient Anesthesia Recovery Team

24 PROCEDURE PLANNING: OR or CATH LAB? COMMUNITY OR LARGE FACILITY Operating Room Cardiac Cath Lab or IR Suite Endovascular Surgeon Where majority of cases done by IC/IR

25 WORKING WITH ANESTHESIA Select first an anesthesiologist comfortable with Once adopted, value of Fast-Track EVAR is easily apparent. Teaching institutions for anesthesia are ideal another way of educating the anesthesiology residents or CRNA students. Once cooperation is ensured and initial is observed anesthesia was highly encouraged to pass along the success by way of teaching their CRNA residents.

26 TEAM TRAINING AND/OR EXPERIENCE NURSES SUPPORTING EVAR PROCEDURE RECOVERY/FLOORS Trained in interventional or endovascular procedures, as well as management of patients undergoing sedation. Trained in the management of closure devices. The nurse should be able to monitor for complications, etc.

27 RECOVERY IF DONE IN Operating Room Cardiac Cath Lab or IR Suite PACU Holding Area

28 WHY IS CRITICAL CARE MONITORING LESS IMPORTANT FOR LIFE FAST-TRACK REGISTRY? In the LIFE Fast Track Registry, Only 4% (11/250) patients were admitted to the ICU Only 2% (6/250) underwent general anesthesia. No procedure-related adverse events throughout their hospital stay and through 30 day follow-up.

29 POSITIVES FOR PATIENT CARE WITH FAST-TRACK As demonstrated in the FAST-Track Registry, patient satisfaction is significant. Hours to ambulation were 50% less Patients who underwent bilateral percutaneous EVAR with general anesthesia Took more than 2x longer to ambulate Hours to normal diet were also lower QOL change was highly significant Once hospitals see initial success, adoption will only grow

30 HOW DO YOU BEST RELATE TO ADMINISTRATION? Educate administration on advantages, such as fewer patients in ICU and less hemodynamic monitoring afterwards Extrapolate benchmark data to compare against your historical EVAR data to show its significance Administration will note the cost savings.

31 Naples Experience 15 patients underwent FAST-Track EVAR between Jan Sept o 11 Ovation Prime Abdominal Stent Graft o 4 AFX AAA System Mean age 73 years Technical success was achieved in all but one patient who underwent bilateral PEVAR but converted to a cutdown on one side upon closing. No general anesthesia No postoperative ICU 100% next day discharge No 30d MAE No 30d hospital readmissions were recorded. 31

32 FAST TRACK EVAR CONCLUSIONS May be safely accomplished by experienced users in high volume community hospital settings High quality patient outcomes will be afforded by early ambulation, diet, and discharge Healthcare system efficiencies can be netted from reduced length of stay, reduced hospital readmissions, and avoidance of expensive support therapies 32