Vascular Device Forum

Dialysis Access Coding: Are you Optimizing Sean Roddy Veith Meeting

Sean Roddy MD from the Albany Vascular group presented several sessions on optimizing coding for procedures. This takes on increasing importance in this day and age of annually diminishing physician technical reimbursement.

With regards to dialysis access, one area of apparent confusion was related to coding of venous angioplasty. Venous Angioplasty G093 coding is used for within the dialysis circuit to the axillary level. beyond this area, separate coding is used for central venous angioplasty.  Remember that there is a 30 day global for percutaneous dialysis declotting

From the Veith Meeting: Are live cases justified

This morning's session included a presentation on the use of "live case presentations" Formerly a method of presentation at the Veith Meeting but no longer used. Live case presentations are more commonly seen at catheter based conferences usually associated with interventional radiology IR and Interventional Cardioloy IC.

The controversy surrounds the informed consent process which theoretically should include a discussion with the patient that the operation will include the procedure and its risk plus the discussion of the simultaneous narrative to the audience by the physician and the fact that this may theoretically result in some level of distraction which might theoretically result in untoward outcome.  Although I understand his concern, for those of us who operate in a teaching environment, were constantly narrating and discussing the education aspects of the procedure to our resident, medical student, assisting nurses, anesthesiologist. So how does it differ if we have a microphone attached and a closed circuit camera in the room

Bottom line: live case demonstrations will probably become less frequent due to theoretical medical liability issues.

Updates from the Veith Meeting-Dr Tom Fogarty on innovation

Dr Tom Fogarty presented a session on the changing face of innovation in medical device and the challenges faced within the US. He focused on the increased regulatory environment in the US compared to Europe and Asia. Noting that the cost of development for what ultimately became known as the fogarty catheter in 1962 was about $2000 while the 2000 R&D costs for development of drug eluting stent technology is over $250 million for the stent and $3 million for the drug. Clearly these costs far outstrip adjusted inflation.

His conclusion is that more and more medical device R&D will occur outside the US particularly in the EU

Viabhan endo graft from gore: A practical protocol for use from The Veith Meeting

From the Veith Meeting, work was presented on the use of the ViaBahn Endograft by Gore Vascular. I have had a lot of difficulty figuring out how the Viabahn fits into my practice. This talk was a very even handed presentation of PTA, Nitinol Stenting and Viabahn in the treatment of SFA disease. There is very compelling randomized work suggesting that Viabahn endografting works well for longer SFA lesion >10-15 cm.  For <5 cm PTA works well or for that matter, any therapy. for 5-10 cm Nitinol works well. 

My concern with the use of Viabahn is the coverage of collateral and the presentation of acute thromboses with limb threatening ischema. Several talks were given regarding post op anti coagulation regimens including aspirin, clopidogrel +/- warfarin.

There seems to be a relative level of comfort talking to vascular surgeons regarding the use of Viabahn in popliteal aneurysms.

Evar Follow up based upon simplified protocol for Zenith at Veith meeting

Tim Chuter MD presented an interesting talk this afternoon looking at EVAR follow up. The talk was followed by a similar presentation by Mike Makaroun from Pittsburgh. The background is that the FDA available aortic endografts have various recommended protocols for post operative follow up. All involve computed tomography of the abdomen and pelvis at some interval. Usually a baseline study at one month after implantation followed by CT scan ranging from one at 1year post implant to an aggressive regimen of imaging at 6 mo. 

This protocol involves significant radiation exposure to the patient as well as significant cost to our health care system. Tim Chuter introduced an alternative protocol of baseline CT and KUB at one month. With no endoleak and no clinical suspicions based upon anatomy, he follows up with KUB and ultrasound at one year. The problem is that this protocol requires a good vascular lab and the studies all need to be performed by the same lab, ie technically dependent.

The summary conclusion is that selective imaging of the post EVAR patient may permit a decrease in the use of CT scanning with no detriment to patient care and a significant overall cost savings.

Blogging from the Veith Meeting NYC

The Veith Meeting is always such a great event. New York City in the fall can't be beaten. And the quality of the Meeting is exceptional. If you have ever been at the Veith meeting, you know that the format is a rapid fire 5-7 minute presentation format followed by a panel session with questions. And  5 minutes means 5 minutes. I spoke to Dr Veith briefly today and he reinforced that the timliness of the meeting is so important to how it operates. If you ever roll out of bed to make it to the morning session at 6:30 am, Dr Veith is there and if you are there at adjounment at 6:30 pm, Dr Veith is there. He's amazing

On day one, there were conferences focusing on dialysis access, venous disease, cardiovascular disease and wounds. the dialysis access was surprisingly well attended.  There seemed to be an overall agreement that the fistula first initiative has pushed us to a point of too many non functioning fistulas (failure to mature) in an attempt to meet the 66% benchmark for fistula creation. This usually leads to an increase in fistulas with a corresponding increase in tunneled catheters.

There is wide enthusiasm for the Flair EndoGraft from Bard Medical. This graft has randomized prospective research showing a significant patency advantage compared to PTA at the interface of graft to vein in AV dialysis.

Other controversies one stage vs two stage BVT

Controversy exists regarding the management of catheter infections. Consensus suggested that it is largely dictated by the organism ie staph epi vs staph aureus. Controversy exists regarding role of cath removal vs cath exchange

Dr Lowel Kabnick presented very compelling information to suggest that the use of Sotradecol in foam sclerotherapy might be considered inappropriate off lable use in some circumstances. However the consensus is that foam sclerotherapy is the preferred method for treatment of spider and reticular veins.

Flixene Dialysis Graft may allow immediate needle access

The Flixene Vascular Graft is a next-generation composite graft indicated for vascular access and arterial vascular reconstruction from Atrium Medical Corporation of Hudson, New Hampshire. The graft is built from a proprietary biomaterial film lamination process and offers superior kink and compression resistance. According to the manufacturer, the graft possesses excellent “burst” and “suture strength,” and is resistant to weeping fluid that is often observed with traditional vascular bypass grafts following implantation.

Becaue of the ability to access the graft immediately after implanting(as opposed to normal practice of allowing the PTFE to "incorporate" for 2-3 weeks before access), we have used the Flixene for situations where we would like to avoid a temporary dialysis catheter such as a person with autogenous fistula and aneurysms requiring interposition revision. For this situation interposition of The Flixene allows the uninterrupted use of the access followin revision. The proprietary film lamination permits immediate needle access and sealing of the graft.

Central venous catheter placement is associated with a significant incidence of central vein stenosis within the insersion site Internal Juglar and Brachiocephalic Arch region. Studies have demonstrated central venous thromboses in up to 30% of patients following central catheter placement. Additionally the infectious complications of central catheters are well documented.

The challenge for Atrium Medical is that with increasing pressue to pay for perfomance and best practice for fistula creation the placement of autogenous grafts is becoming less frequent

Boston Scientifics Wallstent receives FDA approval

The FDA has granted approval for Boston Scientific's Wallstent, monorail endoprosthesis. Three years have elapsed since results from the BEACH trial summarized outcomes associated with the use of the Wallstent. Since that time devices from Abbot, Cordis, EV3 and the NextStent from Boston Scientific have received approval. The device landscape or carotid stents is crowded. Even in the context of CMS limiting reimbursement to greater than 70%, symptomatic lesions. So although the relative population of treatable patients is static, the available devices has expanded

Positive Results with Abbot's Bioabsorbable Stent

October 13, 2008 -- Abbott (NYSE: ABT) today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries. Patients who received Abbott's bioabsorbable drug eluting coronary stent and were followed out to two years experienced no stent thrombosis out to two years and no new major adverse cardiac events (MACE) between six months and two years. These results confirmed earlier positive one-year clinical results with Abbott's bioabsorbable drug eluting stent. The results were presented today at the Cardiovascular Research Foundation's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium

Cook Submits Application on Low Profile EVAR Device

Cook Medical announced submission of application for approval for a low profile endograft system for treatment of Abdominal Aortic Aneurysm (AAA). The low profile system is 16 Fr. in size compared to current diameters of 22-24 Fr for the main body. The large main body device profile may affect the ability to insert the device in under the circumstances of small access site diameter which is more common in women. Inability to insert the device at traditional access points in the groin may necessitate a more invasive pelvic incision or the inability to perform stent grafting and the need for traditional aneurysm surgery via an abdominal incision.

If approved, this technology improvement may reverse halt the slide in market share created by entry of the Talent Endograft from Medtronic. Although I have not seen the numbers, my perception is that there has been a migration to the Talent by some previous users of The Zenith device.

I would like to get some feedback regarding the number of proceduralist who would use percutaneous technique for the 16 Fr. It's a somewhat contradictory thought process that the subgroup that would most benefit from the small device size (elderly female, small vessels) is precisely the group that's most prone to complications from an attempt at percutaneous management of a 5 mm arteriotomy.

Editors note: The Veith Meeting is coming up. I hope to provide some real time updates regarding technology and industry events

Reationships between Cardiology and Industry Investigated

While they still haven't passed a law forcing drug companies and medical device firms to disclose payments to doctors--as some influential legislators still hope to do--that doesn't mean lawmakers are letting the subject rest on Capitol Hill. In fact, they're keeping the heat on high.

This week, Sens. Chuck Grassley (R-IA) and Herb Kohl (D-WI)  sent requests for information on whether Columbia University and the Cardiovascular Research Foundation have received money from the medical-device industry. The letters follow a similar investigation that kicked off a few months ago, in which Sen. Kohl sent a letter asking the American College of Cardiology to explain some aspects of its relationship with CRF.

The senators want to know whether research physicians affiliated with these institutions received medical-device industry payoffs. Grassley and Kohl also would like to know more about the Cardiovascular Research Foundation's financial support for an annual conference that just happens to promote cardiac devices and techniques. (Did we mention that CRF just happens to get funding from medical device manufacturers like Medtronic and Boston Scientific Corp.?) They'd also like more data on financial relationships between professors of medicine and cardiac-device companies featured at the conference.

Several individual states have already passed laws requiring similar disclosures, including Vermont, Maine, Minnesota and West Virginia. If the Physician Payments Sunshine Act passes, meanwhile, pharmaceutical companies or medical device makers would face similar requirements everywhere in the U.S.

From the Wall Street Journal "Sens. Chuck Grassley and Herb Kohl are making a habit of delving into financial ties between high-profile doctors and the drug and device industries.

The latest salvo came today, as the senators sent letters to Columbia University and the Cardiovascular Research Foundation, asking about payments from stent makers to the institutions and affiliated doctors.

CRF’s founder, Martin Leon, as well as its current chairman, Gregg Stone, are both stent specialists affiliated with Columbia, and both are among the doctors listed by name in the letters. The foundation receives funding from device makers, among other sources, and conducts research.

The letters also ask for info about ties to a few companies in particular, including Abbott, Medtronic, Boston Scientific and Johnson & Johnson — the four shops that sell stents in the U.S."