Novel solutions for access challenges

Transcription

1 Novel solutions for access challenges Mr James Gilbert Consultant Transplant & Vascular Access Surgeon

2 Disclosures I have the following potential conflicts of interest to report: I currently hold a consultancy contract with Merit Medical and am paid for any work undertaken.

3 Good Pump Speeds Normal Pressures Process good volumes Excellent Adequacy

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5 Consuming the real estate RRT journey - 2 or more lines (tunneled) - 3 or more fistulae - AV Graft(s) Transplants An increasing access challenge Especially if develop CVS / CVO

6 End Stage Vascular Access End stage access is reached when all autologous vein options and conventional graft and catheter placements have been exhausted or are not possible and there is the presence of central vein pathology (Gilbert VASBI 2014)

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10 Venous Hypertension

11 CVO a significant problem in vascular access An estimated 2M people worldwide require treatment with dialysis or kidney transplant to stay alive 1 But Central venous catheters (CVCs) continue to be used as a bridge while waiting to secure access Arteriovenous Fistulas (AVFs) remain the preferred form of vascular access Chronic CVC use leads to central venous obstruction (CVO) in 40% of cases Data on file at Bluegrass Vascular Technologies, Inc.

12 HD Catheters associated with High morbidity caused by - Thrombosis - Infection Cause central venous stenosis or occlusion Shorter use-life than other access types Overall lower BFR and reduced adequacy requiring longer dialysis times

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14 Long-Term Consequences 20% 40% 40% 60%

15 Potential Market for Occlusions Access Centers Country Population (M) Dialysis Patients (K) Fully Occluded Symptomatic Partial Occluded Total High Volume Centers Standard Total Germany 84,500,000 85, Turkey 78,200,000 41, United Kingdom 65,000,000 25, Italy 61,000,000 33, Spain 46,000,000 21, Scandinavia 20,600,000 5, Netherlands 17,500,000 5, Belgium 11,300,000 7, Austria 60,000,00 4, Total 390,100, ,

16 What could we do? Leave them on a line (wherever we can place one) Consider a Heroic Intervention Any procedure or intervention that seeks to treat or bypass Central Venous Pathology (CVP) to enable: - Autologous access or grafts to function - Treatment / prevention of venous hypertension

17 Heroic Options: Use of Lower Limbs Angioplasty / Stenting CVS Atypical / Exotic access / bypass procedures HeRO graft Insertion Surfacer Inside Out Catheter System

18 Hemodialysis Reliable Outflow (HeRO) Treatment option for ESVA patients Only fully subcutaneous AV access option that offers long term access in CVS Option for patients with failing AVF or graft due to CVS Option for the catheter dependent or approaching catheter dependence patient with CVS

19 HeRO is a 2 Component Device

20 Venous Outflow Component Braided Nitinol stent Covered with Silicon Kink Resistant Crush Resistant HeRO is a Customizable, Sizeable REMOVABLE stent

21 Arterial Graft Component Venous Outflow Component

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27 3 TCC s in 3 years! 3 AVF attempts, Right B/C AVF eventually successful 18 months venous hypertension (arm, face, tongue, vocal cords!) Home Haemo patient, agrophobia, wants to stay that way!

28 Left IJ HeRO Necklaced across to right side Joined onto Right B/C AVF Maintained needling areas Instant symptom relief

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30 Clinical Outcomes HeRO Graft Oxford 0 NA 84.6 % 1.125

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32 Make your own with Super HeRO Super HeRO Adaptor first product of its kind in vascular surgery Coupling device that allows for certain grafts to be used with HeRO Outflow Component Avoids graft to graft anastomosis Adapter

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37 Current Last Option Access Alternatives Heroic attempts to re-canalise but low success rates (50% approx) Undesirable access sites used but high infection rates and poor patency Translumbar & Transhepatic Incision in midabdomen (lumbar region) Discomfort, risk, poor stability, infection, bleeding Transiliac Incision across the pelvic region Restricted movement, infection, DVT risk, poor stability, poor ICD shock vectors Thoracotomy Incision into the chest Invasive, not easily repeated

38 Delivery Instrument Restores central venous access via an Inside-Out approach Exit Introducer C O M P O N E N T S 1. Sheath/dilator 2. Delivery instrument 3. Introducer 4. Skin exit marker Workstation

39 THE CENTRAL VENOUS SYSTEM Images courtesy of Mike Winkler, MD, University of Kentucky 2015 Generously provided by Dr. John Gurley

40 Proximity to Head of Clavicle View (looking from the back to front) View from front Images courtesy of Mike Winkler, MD, University of Kentucky 2015 Generously provided by Dr. John Gurley

41 Relationship to Arteries Arteries BEHIND veins Veins BEHIND bone Anterior needle path from head of clavicle always safe Images courtesy of Mike Winkler, MD, University of Kentucky 2015 Generously provided by Dr. John Gurley

42 The Surfacer System Only formally marketed device to specifically restore access when central veins are blocked Semi-automated and uses an inside-out approach Safe, effective, predictable and repeatable Product used by Interventional radiologists Vascular access surgeons Interventional nephrologists Applications Dialysis, chemo, nutrition, pacing

43 Surfacer System in patients for whom this ntraindicated. e Precautions access site management per institutional protocol and post hospital discharge to maintain patency and n. RAMETERS e venography or optional venous duplex of the upper C, jugular, inferior vena cava (IVC), brachiocephalic ). e anterior e posterior (AP) and lateral chest x-ray with the pat ter n of occl usi ons and to rul em out acu te ocedural screening diagnostics and confir exit location. Main Sheath p onent s of the Sur facer System are described n Sheath - the Workstation Sheath provides access heral venous system via the femoral vein. The Sheath provides a lumen for the Surfacer Device, njury when it is advanced. See Figure 1. re 1: Surfacer Workstation Sheath Needle Guide Knob Needle Guide angle indicator 3. Exit Target Surfacer Device has 95 cm effective Dilator hublength HANDLE Needle Wire clamp switch Handle Plunger The Exit Target is a radiopaque marker use to locate the desired Needle o Wire exit location (the supraclavicular space) using flur oscopi c ima gi ng. See Figure Peelable Introducer Figure 3: Surfacer Exit Target Exit Target Needle Wire The Peelable Introducer provides percutaneous access to the venous system and permits insertion of the CVA catheter. The Peelable Introducer has a peelable sheath, valve and dilator. The Peelable Introducer is 16F x 20 cm long. See Figure 4.

44 16 Fr Exit Introducer is ~20 cm long 10 Fr Workstation sheath and dilator is ~65 cm long Dilator Workstation Dilator Tuohy-Borst Connector Workstation Sheath Peelable Sheath Exit Target

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52 Important to image!!!

53 3 Centre Clinical Experience Vienna, Cologne & Oxford 43 potential cases in 36 patients analysed 4/43 cases excluded as contraindicated 2 = occluded Right CFV, 2 = juxta atrial SVC occlusion and unsafe to advance wires 39 cases undertaken in remaining 32 patients Reviewed time & success of procedure and complications

54 Parameter Measures Number of patients 36 Age (years) 59 (20 82) Sex (Male : Female 10 : 36 Previous CVC 36 [100 %] Central Vein Obstruction type Type 3: 30 [83%] Type 2: 3 [8%] Type 1: 3 [8%] Patients eligible for procedure 32

55 Parameter Measures Surfacer procedures performed (in 32 patients) 39 Successful placement 38 (97%) Re-interventions (>3 months after primary intervention) 7 (18%) Duration of procedure 43 min ( min) Fluoroscopy time Volume of contrast agent 6 min (2-14 min) 15 ml (0-90 ml)

56 Closing Remarks Central Vein pathology is an increasing problem and more likely if history / presence of a TCC The HeRO graft is only subcutaneous AV access option that can bypass CVS and provide reliable dialysis Restoring Central access in CVO is safe and possible using the Surfacer Inside out System Both are associated with good outcomes