State of the Art of PEVAR Zvonimir Krajcer, MD Program Director- Peripheral Vascular Interventions Department of Cardiology, St. Luke s Episcopal Hospital and Texas Heart Institute, Houston, TX
Disclosures On the speaker s bureau for W.L. Gore, Endologix, Medtronic, Volcano, Abbott Vascular, Lombard Training courses for: W.L. Gore, Endologix, Medtronic, Volcano, Abbott Vascular, BARD Consultant for W.L. Gore, Endologix, Medtronic, Abbott Vascular Off-label use of some products may be discussed
EVOLUTION of AAA REPAIR Less Invasive Therapeutic Option Open Surgical Repair EVAR with Surgical Cutdown Percutaneous EVAR 30 day Mortality 4.3% 1.8% Surgery EVAR Source New England Journal of Medicine 2010; 362:1863-1871 Ovation Pivotal Trial 0.6% 30 day Major adverse event Rate 56% 11% Journal of Vascular Surgery, March 2010, Turnbull et al; Journal of Vascular Surgery, September 2008, Zwolak et al 2.5% Length of Hospital stay (days) 10.4 3.6 Journal of the American Medical Association 2012; 307(15): 1621-1628 2.3
Large Vessel Closure: Prostar XL 10Fr Braided SM VCD Two sutures (braided polyester) Four nitinol needles Monorail design.038 wire compatible Integrated pre-dilator Knot pusher
Prostar Non-Randomized Single Center PEVAR Published Outcomes Author Year Sheath Fr. Pts Access Sites Technical Success Haas 1999 16-22 12 13 100% Traul 2000 16-24 13 26 46%/64% Teh 2001 16-22 44 82 75%/85% Howell 2001 16 144 144 94% Rachel 2002 16-22 44 88 63%/76% Over last 5 years, Technical Success ~ 96% Howel 2002 16-22 30 60 93%/96% Börner 2004 14-20 95 190 82%/89% Morasch 2004 12-18 47 94 85%/93% Quinn 2004 12-18 63 100 96% Starnes 2006 12-24 49 79 92%/94% Arthurs 2008 nr 88 152 95% Smith 2009 nr 22 38 100% Eisenack 2010 14-24 500 903 96% Krajcer 2010 21 57 38 98% Krajcer 2011 21 38 44 97%/98%
Perclose ProGlide 6Fr SM Monfilament VCD Now VCD for large sheath closure (12-21F)
ProGlide Non-Randomized Single Center Published PEVAR Outcomes Author Year Sheath Fr.. Pts Access Sites Technical Success Dosluoglu 13 2007 12-22 17 34 81%/90% Lee 29 2007 12-24 101 173 89%/94% Over last 5 years, Technical Success ~ 96% Lee 30 2008 12-24 292 432 94% Bent 15 * 2009 18-26 21 29 95%/97% Smith 26 2009 nr 22 38 100% Grenon 14 2009 15-24 15 nr 93% Jahnke 16 * 2009 12-24 70 132 96% Bensley 32 2012 12-24 168 296 96% Sarmiento 39 2012 12-24 101 nr 90% Al-Khatib 41 2012 12-24 168 24 96%
PEVAR provides benefits across the health care delivery spectrum* Patient Benefits Physician Benefits Hospital Benefits Minimally Invasive Lower anesthesia time Avoid GA complications Less blood loss Fewer groin complications Less pain Quicker recovery time Quicker procedure No anesthesia delay Patient satisfaction Improved efficiency Patient satisfaction Lower infection rates Lower cost Less blood transfusion Improved efficiency *As reported in single center publications
Several factors may contribute to success! Patient-specific 1 Physician-specific 2 Device-specific 3 Vessel Diameter Vessel Calcification Body Mass Index Gender Vessel Tortuosity Experience -SMCD Presence of multispecialty team Use of ultrasound AAA Endograft Sheath-based Delivery Profile Suture-mediated Closure Device Presence of PAD 1 Lee et al. J Vasc Surg 2008; 47:919-23; Al-Khatib et al. Ann Vasc Surg 2012; 26: 276-82 2 Bechara et al. J Vasc Surg 2013 Jan;57(1):72-6 3 Georgiades et al. J Endovasc Ther 2011;18:445 459
PEVAR Trial Results: Primary Endpoint Results FDA Approved, Prospective, Multicenter, Randomized Trial of Percutaneous EVAR PEVAR ProGlide N=50) SEVAR (N=50) Difference 95% CI p-value Major Ipsilateral Access Site Vascular Complications at 30 Days 6% (3/50) [1.3%, 16.5%] 10% (5/50) [3.3%, 21.8%] -4.0% [ -, 4.9%] 0.0048 PEVAR ProGlide SEVAR p-value Procedure Time (mins) 106.5 ± 44.9 141.1 ± 73.4 0.0056 Time to Hemostasis for Ipsilateral Access (mins) 9.8 ± 17.0 22.7 ± 22.9 0.0023 1.Krajcer Z, Nelson PR et al. J Cardiovasc Surg (torino). Oct 2011;52(5):651 2.Krajcer Z., Matos JM. THJ 2013;40(5):560 3.Nelson PR, Krajcer Z. J Vasc Surg. May 2014;59(5):1181
How to further reduce morbidity/mortality and the cost of EVAR? 1. Percutaneous Femoral Artery Access and Repair, 2. Local Anesthesia and Conscious Sedation Texas Heart In
Texas Heart Institute Fast-track EVAR (1997-2014) Bilateral percutaneous access whenever possible using a pre-close technique (Prostar or ProGlide) (PEVAR) Local anesthesia and conscious sedation No Foley catheter No CVL No radial line No NG tube Interventional floor admission (No ICU) Ambulate in 4-8 hrs Normal diet within 2 hrs post procedure Next-day discharge
Texas Heart Institute Fast-Track EVAR RESULTS 1997-20014: 1457 pts. (78% ) Since 2000: 98% Prostar technical success: 97% ProGlide techical success: 96% Blood transfusion: 2% Conversion to General Anesthesia: 0.1% Hospital mortality: 0.3% Access site infection: 1%
LIFE Study Least Invasive Fast-Track EVAR Screening During Procedure Post Procedure Plan for success Minimize complications Minimize hospital stay Suitable for P-EVAR with Ovation Prime No comorbidities requiring extended hospitalization Percutaneous access Local/regional anesthesia No ICU if not required Early ambulation &diet Next day discharge TriVascular Ovation Prime Abdominal Stent Graft System
In the Next Decade We Will See Increasing Use of VCD Increasing trend for outpatient PCI and other intrventions, which will require safe and early ambulation Increasing demand for large profile device use and desire to avoid arterial cut-downs such as for EVAR, TEVAR & TAVR
Emerging Large Vessel Closure Devices Category Company Device Suture based Sutura/Medtronic Superstich Suture based SpiRx SpiRx MSD Patch or Plug Vivasure Vivasure VCD Patch or Plug Access Closure Closure- GRIP Scaffold&Cover InSeal Atum Scaffold &Cover ProMed ProMed VCD Patch& Plug Essential Medical Manta Investigational devices
MANTA Technology 18F 14F Toggle MANTA 18F FIM Suture Safety Wire Tamping Tube
MANTA 18F Clinical Study FIM 5 pts enrolled November 2014 No major or minor complications EU Study:17/50 patients to date Procedures: TAVR, BAV, VAD, EVAR Median Time to Hemostasis: 26 sec 0 Major complications 1 Minor complication
Summary There is ample evidence from many single center studies and randomized PEVAR Trial that PEVAR offers significant benefits in comparison to SEVAR. Fast-track EVAR protocol characterized by percutaneous access and local anesthesia has enabled us to further reduce morbidity, procedure time, time to diet, time to ambulation, LOS and cost. New generation dedicated large bore closure devices offer encouraging preliminary results