The Continuing Role of Pushable Coils: Advances and Fiscal Responsibilities JAMES F BENENATI MD

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1 The Continuing Role of Pushable Coils: Advances and Fiscal Responsibilities JAMES F BENENATI MD

2 James Benenati, MD Royalty: Penumbra Stock: Covidien Consultant/Advisory Board: Penumbra, Endoshape, Scientia

3 So, what is the issue? Better tools and devices More expensive tools and devices Do the advantages provided by the more expensive tools justify the cost? 4

4 Related to Coils Coil Embolization: Fiscal Considerations Coil Type.035 vs microcoils Pushable vs detachable Plugs ( occluders) and new coil types Coil Delivery systems Standard catheters Microcatheters Coil pushers 5

5 Coil Embolization: Fiscal Considerations Related to Anatomy Target vessel embolization diameter Small vessel vs large vessel or aneurysm Access to embolization sight Tortuosity, vessel size Proximity to braches and non target vessels 6

6 Coil Embolization: Fiscal Considerations Cost considerations $.035 pushable <.018 pushable < detachable Role of occluders and plugs Number of coils needed ( do lots of less expensive coils cost more than a few expensive devices) Packing density in aneurysms Coils length & coil thickness influence number of coils and type of coils and ultimately cost 7

7 Is Coil Packing Density Important? Recent study demonstrated that insufficient coil packing density within visceral aneurysms resulted in an increased incidence of coil compaction and recanalization There was no recanalization or compaction in aneurysms with a packing density of at least 24% Yasumoto T, Osuga K, Yamamoto H, et al. Long-term outcomes of coil packing for visceral aneurysms: correlation between packing density and incidence of coil compaction and recanalization. J Vasc Interv Radiol. 2013;24:

8 Clinical Efficiency of Large Volume Coils 4 Large Volume Coils 9. micro Coils Copyright Penumbra, Inc. All rights reserved. 7516, Rev. C 9

9 Coil Embolization: Fiscal Considerations Coils choice considerations Time & radiation exposure to physician and patient Cost of procedure Safety Precision Lack of experience of operator Medical-legal considerations ( risk of non target embolization may be reduced) 10

10

11 Save time by injecting micro coils when you are in a safe location Many IR embo procedures can be done by injecting micro coils Push with 1cc saline syringe Saves time Easy to do Safe in selected cases

12 BE CO$T EFFICIENT: Choose inventory judiciously 5f cobra catheter: $13.00 Micro catheter: $ Nester or.018 Nester $85.00 Detachable coils: $753-1, If you can coil something with an.035 coil and a cobra but you choose a micro catheter and a detachable coil the difference would be: $98.00 vs. $2, for the first coil & >$700 for each additional coil

13 Peripheral Vascular Embolization Limitations of pushable coils: Often require multiple coils for effective embolization longer procedure times, additional x-ray & contrast exposure to patient and physician Image artifact from coil mass Thrombogenicity can vary by degree of coil packing Lack precision in delivery, resulting in non-target embolization Facilities need to carry many sizes and types Limitations of plugs sensitive to sizing, can have long embolization times, limited trackability 14 Confidential

14 Detachable vs. Pushable in the Periphery Large Volume 1 Detachable Coil.018 Pushable Coils # of coils Avg Cost / unit $1,200 $150 3 Total Cost $1,200 $1,800 Can be a savings or a loss 1 2 Prospective comparison of hydrogel-coated Microcoils versus Fibered Platinum Microcoils in the Prophylactic Embolization of the Gastroduodenal Artery before Yttrium-90 Radioembolization, Maleux et. Al, JVIR 2013; 24: Avg Cost of Detachable Terumo Hydrocoils and Fibered Boston Scientific Target Microcoils

15 Multi-Coil Device Constructed from multiple polymer coils Proprietary durable radiopaque polymer technology Polymer strands can be formed to multiple lengths, sizes and shapes depending on clinical and anatomical need Confidential 16

16 Cost Effective Coil Volume Comparison Coil EndoShape Medusa MMC Penumbr a Ruby Coil BSC Interlock 35 Covidien Concerto/ Axium Terumo Azur CX List Price $1800 $1590 $900 $850 $1200 Cost by Volume Coil Thickness Longest Coil $1,800 $2,703 $5,130 $5,525 $6, Coils x 15.6CM 60cm 20cm 30cm 24cm # of Coils needed to = 1 Medusa

17 Coil Embolization: Fiscal Considerations Embolization examples target.035 pushable.018 pushable Detachable plugs combo Varicocoele ideal ideal Not necessary Pre-Y 90 Too big Most cases for length or to cap vessel Visceral aneurysm IIA aneurysm PAVM ++++ primary Too big +++ Packing density Framing: density ++++ Too small Framing coils density Less expensive +++ safety Mciro plugs Micro plugs primary

18 EDITORIAL Coils and Cash: What Coil Vendors Don t Want You to Know My problem lies in reconciling my gross habits with my net income. Errol Flynn American Journal of Neuroradiology August 2009 February 2009Volume 20, Issue 2, Supplement, Page S80 19

19 Despite a large increase in competition in the marketplace, detachable coil prices have continued to rise. Perhaps the single largest contributor to coil cost escalation is that physicians are generally not sensitive to device pricing because their salary and resources have not been directly related to hospital costs. Physicians thus have tended to choose coils with little regard to cost. We now have coils on the market ranging in list price from $500 to $3000. cerebral aneurysms are unusual in that we generally need several expensive coils to treat a single aneurysm, and adding a stent for cerebral aneurysm treatment, which costs $5200 to $5300 each, makes the coils look cheap. In a recent study, it was shown that the hospital costs for coiling an aneurysm at a single center in the United States were one-third higher than the costs for clipping, largely because several coils cost much more than a single clip. 20

20 Many neurointerventionalists are uninformed regarding the cost and reimbursement of medical devices. There seems to be a widespread misconception that when we use a coil, the hospital then charges for that coil and then the hospital gets reimbursed for that coil. In reality, that is not what happens for many, and perhaps most, of our patients. What often happens is that the third-party payers pay a limited amount for care of a patient with a specific problem. In 2008, the national average payment by Medicare for the entire hospitalization for the uncomplicated endovascular treatment of an unruptured aneurysm was $12,599. Just the access materials (guide catheter, microcatheter, microguidewire, etc) cost at least $1000. If you use 12 coils at $1000 each or if you use a stent for $5200 and 7 coils for $1000 each, then you have spent more than the entire Medicare reimbursement on devices, and every other expense related to the hospitalization is a financial loss to the institution. 21

21 Conclusion Pushable coils are cheap :.035 coils are easy and inexpensive. These coils may work well in a large number of embolization cases However, certain situations require detachable coil or plug technology Large volume detachable coils can be fiscally responsible, clinically efficient and reduce radiation exposure Remember that decisions on device type will affect cost

22 23

23 Results Aneurysm/Malformations Results Number of Aneurysms or Malformations, N Volume, Median [IQR] Range Number of Coils Deployed, Median [IQR] Values mm 3 [IQR ] mm 3 5 [IQR 3-8] Fluoroscopy Time, Median [IQR] 24.5 Minutes [IQR 17 36]

24 Results Vessel Sacrifice Clinical Outcomes Number of Cases, N 36 Number of Coils Deployed, Median [IQR] Value 3 [IQR 2 4] Fluoroscopy Time, Median [IQR] 21.0 Minutes [ ]

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