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Gore Peripheral Vision November 2009
Performance Through Collaboration
           
  In This Issue  
 
NEWS
CASE STUDY
ENDO UPDATE
PRODUCT UPDATES
   
REIMBURSEMENT CORNER
CLINICAL STUDIES
EVENTS
CLINICAL LITERATURE
 
     
  Printable PDF Version | Download Adobe Reader  
  In The News BACK to TOP  
       
 

The Evolution of Design

   
  W. L. Gore & Associates (Gore) has made a number of modifications to the GORE VIABAHN® Endoprosthesis, demonstrating the company's commitment to continuously providing its customers with innovative solutions. Recently Gore received approval from the US Food and Drug Administration (FDA) to market the most up-to-date design of the GORE VIABAHN® Endoprosthesis for device diameters 9 - 13 mm. The large diameter product now enables streamlined deployment on the same 0.035" guidewire and TIP to HUB direction as the 5 - 8 mm sizes. Additional modifications to the large diameter GORE VIABAHN® Endoprosthesis include heparin bioactive surface, radial device expansion and a lower profile that is now available for some configurations. More  
       
  Case Study BACK to TOP  
       
 

Revascularization of the Iliac Artery with the GORE VIABAHN® Endoprothesis with Heparin Bioactive Surface*


Jeffrey D. Trachtenberg, MD,
St. Mary's Hospital, Decatur, Illinois


CLINICAL CHALLENGES

The patient is a 62-year-old man with known peripheral arterial disease who is status post-stenting of the left common iliac and superficial femoral arteries in 1998. The patient presented with worsening short distance claudication of the right lower leg. His past medical history includes coronary artery disease, hypertension and hypercholesterolemia. He is a former smoker, having quit in 2005. His current medications include atorvastatin, diltiazem and aspirin. His ankle brachial index on the right was 0.52 and on the left was 0.84. Arterial duplex suggested a right iliac occlusion and this was confirmed by CT angiogram (Figure 1). More
 
       
  Endo Update BACK to TOP  
       
 

Investigation of the Hemodynamic Effect of StentWires on Renal
Arteries in Patients with Abdominal Aortic Aneurysms Treated with
Suprarenal Stent-Grafts


Zhonghua Sun and Thanapong Chaichana
Journal: Cardiovasc Intervent Radiol (2009) 32:647-657


Purpose: This study was designed to investigate the hemodynamic effect of stent struts (wires) on renal arteries in patients with abdominal aortic aneurysms (AAAs) treated with suprarenal stent-grafts. A computer simulation based on real patient data was used to investigate whether there is any significant interference of suprarenal stent wires with renal blood flow, based on variable stent wire crossing and different wire thicknesses. More
 
       
  Product Updates BACK to TOP  
     
 

New GORE PROPATEN® Vascular Graft Line Extensions Released


To continue to meet your needs, we have released additional catalogue numbers to the family of GORE PROPATEN® Vascular Grafts.

Catalogue
Number
Description Internal
Diameter (mm)
Ringed
Section
Length (cm)
Length (cm)
H470080A Standard-walled,
stretch technology
4 - 7 N/A 80
H050060A
[ Coming Soon ]
Standard-walled,
stretch technology
5 N/A 60
H060060A Standard-walled,
stretch technology
6 N/A 60
H080060A Standard-walled,
stretch technology
8 N/A 60
HT074050A Thin-walled,
removable ring,
stretch technology
7 40 50
HT076080A Thin-walled,
removable ring,
stretch technology
7 60 80
 
     
  Reimbursement Corner BACK to TOP  
     
 

Highlights of the Medicare Final FFY2010 and Proposed CY2010 Rules


Medicare CY2010 Proposed Rule for the Physicians Fee Schedule Payment Policies


The Medicare CY 2010 Proposed Rule for Payment Policies paid under the Physicians Fee Schedule was put on public display on July 1, 2009. This proposed rule contains two provisions that have potential significant impact to physician payments. The first is new survey data that CMS has incorporated into the PE (practice expense) component of the RVU (relative value unit) calculation for CY2010. This results in significant RVU shifts between certain CPT® Codes. The AMA administered a new survey in CY2007 and CY2008, the PPIS (Physician Practice Information Survey) with 51 medical specialty and health care professional groups. CMS believes it to be the most comprehensive PE source of data to date.

The second significant provision is the conversion factor amount which is used to convert the RVUs to the Physicians Fee Schedule Payments. The methodology is mandated by Congress and termed the SGR (sustainable growth rate). The proposed CY2010 SGR amount is a decrease of 21.5% from the CY2009 SGR amount. In past years, a similar significant decrease was proposed and it was moderated by Congress. There are provisions in the current proposed Congressional Health Care Reform bills to revise the SGR calculation. The AMA and specialty medical societies may have more information regarding this issue.

The Medicare Final CY 2010 rule will be posted no later than October 31, 2009 and will be effective January 1, 2010.

Medicare FFY2010 Final Rule for the Hospital Inpatient Prospective Payment System (IPPS)


The Medicare FFY 2010 Final Rule for the Hospital Inpatient Prospective Payment System (IPPS) was posted on August 1, 2009. Hospital inpatients are paid on a per admission basis under the MS-DRG methodology. The FFY2010 relative weight calculations were based on the final transition year of a cost-based method from a charge-based method.

The payment rates as published in the FFY 2010 Final Rule were slightly increased over the FFY 2010 Proposed Rule. This increase was in part due to no payment reduction for the documentation and coding adjustment.

This FFY2010 Final Rule provisions will be effective October 1, 2009.

Medicare CY2010 Proposed Rule for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC)


The Medicare CY2010 Proposed Rule for the OPPS resulted in slight increases in most payments and no other significant changes.

The Medicare CY2010 Proposed Rule for the ASC continues the payment methodology transition to a percentage of the OPPS payment amounts.

The Final CY2010 Final OPPS and ASC rules will be posted no later than October 31, 2009 and effective January 1, 2010.


Gore is available to answer your reimbursement questions.
For more information, contact Antoinette Sheen, Coverage, Coding & Reimbursement Specialist.
Email: asheen@wlgore.com
928.864.2420
toll free 800.528.1866 ext. 42420
 
     
  Clinical Studies BACK to TOP  
     
 
GORE VIPER CLINICAL STUDY  
Objective Evaluate the performance of GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
(5 - 8 mm diameters) in treating long SFA disease (lesions > 15 cm)
Study Design Prospective, non-randomized, multi-center study
Primary Endpoints Primary Patency at 12 months
  • No evidence of restenosis or occlusion within the originally treated lesion based on CDUS;
    PSVR < 2.5
  • No angiographic evidence of stenosis > 50% if CDUS is uninterpretable or unavailable
  • Proportion of subjects experiencing major device related adverse events within 30 days
    of procedure
Secondary Endpoints
  • Primary assisted patency
  • Secondary patency
  • Device related major adverse events at 12 months
VIASTAR Clinical Study European Study-Independent of Gore
Objective Evaluate the performance of GORE VIABAHN® Endoprosthesis with Propaten Bioactive Surface
(5 - 8 mm devices) and bare nitinol stents in treating long lesion SFA disease (lesions 10 - 27 cm)
Study Design Prospective, randomized, multi-center study
Primary Endpoints
  • The primary efficacy endpoint for the study is primary patency measured at one year post-procedure by CDUS and CTA / DSA
  • The primary safety endpoint is a composite of serious procedural (30-day) adverse events, including death, myocardial infarction, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion
Secondary Endpoints
  • Technical and Clinical Success
  • Primary and Secondary Patency at one and two years
  • TVR and TLR at one and two years
 
     
  2009 Events BACK to TOP  
     
 
  Date Name Location
  GORE EVENTS    
  December 10 - 11 Advanced AAA Symposium New Orleans, Louisiana
  December 14 - 15 AAA Percutaneous Workshop Houston, Texas
  January 11 - 12 AAA Percutaneous Workshop Naples, Florida
  January 18 - 19 AAA Percutaneous Workshop Houston, Texas
  January (TBD) Advanced AAA Symposium Phoenix, Arizona
  February (TBD) Advanced AAA Symposium Miami, Florida
  February 15 - 16 AAA Percutaneous Workshop Houston, Texas
  February (TBD) AAA Percutaneous Workshop Chicago, Illinois
  SUPPORTED CONGRESSES    
  January 17 - 21 International Symposium on Endovascular Surgery Hollywood, Florida
  January 22 - 23 Controversies and Updates in Vascular Surgery Paris, France
  January 24 - 26 The Society of Thoracic Surgeons FT. Lauderdale, Florida
  January 27 - 30 Leipzig Interventional Course Leipzig, Germany
  February 25 - 27 European Vascular Course Maastricht, Netherlands
  February 28 - March 3 International Congress XXIII Endovascular
Interventions (Arizona Heart)
Scottsdale, Arizona
 
     
  Literature Recommendations BACK to TOP  
     
 

Dialysis Access

Davidson I, Hackerman C, Kapadia A, Minhajuddib A. Heparin bonded hemodialysis e-PTFE grafts result in 20% clot free survival benefit.
Journal of Vascular Access 2009;10(3):153-156.

Peripheral Vascular Treatment

Lösel-Sadée H, Alefelder C. Heparin-bonded expanded polytetrafluoroethylene graft for infragenicular bypass: 5-year results.
Journal of Cardiovascular Surgery 2009;50(3):339-343.

Malignant Jaundice Treatment

Krokidis M, Fanelli F, Orgera G, Bezzi M, Passariello R, Hatzidakis A. Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil stent versus uncovered Wallstents. Cardiovascular & Interventional Radiology. In press.

AAA

Society for Vascular Nursing (SVN) Task Force for Clinical Practice Guideline. 2009 clinical practice guideline for patients undergoing endovascular repair of abdominal aortic aneurysms (AAA). Journal of Vascular Nursing 2009;27(2):48-63.

Thompson J, Bertling G. Endovascular leaks: perioperative nursing implications. AORN Journal 2009;89(5):839-850.

Sun Z, Chaichana T. Investigation of the hemodynamic effect of stent wires on renal arteries in patients with abdominal aortic aneurysms treated with suprarenal stent-grafts. Cardiovascular & Interventional Radiology 2009;32(4):647-657.

Schwarze ML, Shen Y, Hemmerich J, et al. Age-related trends in utilization and outcome of open and endovascular repair for abdominal aortic aneurysm in the United States, 2001-2006. Journal of Vascular Surgery. In press.

Waasdorp EJ, de Vries JPPM, Sterkenburg A, et al. The Association between Iliac fixation and proximal stent-graft migration during EVAR follow-up: mid-term results of 154 Talent devices. European Journal of Vascular & Endovascular Surgery 2009;37(6):681-687.
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