Question | Pages |
Q1: Diagnosing Currently how are your patients diagnosed with AAA? Do you currently screen for AAA? At what point do you decide to intervene? | 5 |
Q2: Current Treatment How do you currently treat patients with large (5.5 cm or larger) or fast-growing AAA? What treatment options are available, and how do you decide which treatment option to offer? | 6 |
Q3: Open Versus Endovascular Considering the two approaches: - Open-chest or abdominal surgery
- Endovascular aneurysm repair (EVAR)?
Please explain which approach you prefer and why. When (what type of patient or condition) does it make sense to use one versus the other? Do you believe there are any significant benefits, from either the patient or physician standpoint, with open surgical repair in comparison to EVAR? Do you believe there are any significant benefits, from either the patient or physician standpoint, with EVAR? Please explain. | 7 |
Q4: Awareness and Use of Endovascular Stent Products What specific endovascular stent systems are you aware of? Which ones do you use and why? Please specify device brands and/or manufacturers. | 8 |
Q5: Comparison of Stent Products Please compare the following product systems, indicating the strengths and weaknesses of each: - Medtronic’s AneuRx Stent Graft System
- W.L. Gore & Associates’ GORE EXCLUDER Endoprosthesis, Bifurcated GORE-TEX Stretch Vascular Graft
- Cook’s Zenith AAA Endovascular Graft, RENU AAA Ancilliary Graft, Fenestrated AAA Endovascular Graft
- Boston Scientific’s Hemashield Gold Microvel Knitted Double Velour; Hemashield Platinum Woven Vascular Grafts
| 8 |
Q6: Stent Products What factor would be most important in increasing the number of patients you treat using EVAR (increased clinical data supporting technology, increased patient referrals, lower device cost, better products, other)? | 9 |
Appendix A: Click here to review product profile | 10 |
Q7: Awareness Prior to this study, what did you know about Endologix’s PowerLink system, and what was the source of your awareness? | 10 |
Q8: Reaction to Profile How does this product compare to the others on the market and the others that you use (if you are not a PowerLink user)? What are this product’s greatest strengths and weaknesses? | 10 |
Q9: Likely Use of PowerLink for AAA Considering the profile you’ve just reviewed, please discuss how likely you are to use the PowerLink stent graft over other specific products (for both endovascular and open-chest/abdominal grafting). | 11 |
Q10: A one piece system Do you believe there are any significant clinical benefits to Powerlinks unique single piece design and delivery mechanism? How important to you is the fact that it’s a one piece system? What are the benefits you would see versus current systems (time savings, error rate, etc.)? | 11 |
Q11: Facilitators and Barriers to Use What factors might support your decision to use the PowerLink for treating AAA? What specific factors would prevent you from using the PowerLink? | 12 |
Q12: Additional Information or Need What would it take for you to increase your use of: - Endovascular stent grafts in general
- Endologix’s PowerLink system, specifically?
| 12 |
Q13: New & Forthcoming Treatments Are you aware of any treatment approaches or specific therapies in development that could potentially compete with the current endovascular stent grafts in the next 5 years? If so, what are these approaches or treatments, and how do you expect they will fare against the current treatment options? | 12 |
Q14: Trends in Treatment - Looking ahead 1-2 years, what trends do you anticipate regarding the treatment of large- or fast-growing AAA, and why?
- What do you think the growth in AAA stenting will be over the next 12 months?
| 13 |
Q15: SAAAVE Bill Are you aware of the SAAAVE Bill that was passed by congress in 2006 and took effect January 1, 2007? The SAAAVE Bill provides reimbursement for a one time ultrasound screening for Medicare patients with a family history of AAA, and men over the age of 65 who smoke. Do you believe this will increase the number of patients you treat for AAA? | 13 |
Q16: Questions If your job were to evaluate the potential of Endologix’s PowerLink system and you had one hour with the management team of the company, what would you ask the team, and why? | 14 |
 Introduction
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Hello and welcome to MedPanel. We thank you for joining this special discussion among practicing vascular and cardiothoracic surgeons. Our goal in this discussion is to explore with the group the various treatment practices and related issues for abdominal aortic aneurysms (AAA). During this exercise, we will inquire generally about your experience with treating AAA using various methods and/or devices. We will also ask you to review a product profile for a stent-graft and discuss your reactions and likelihood of using the product. As we begin, please keep in mind that these discussions are enhanced when you, as a panelist, not only respond to the posted questions, but also reply to comments made by our moderator and by your fellow panelists. In addition, because this is a sophisticated gathering, you may wish to take advantage of the opportunity to interact with and pose questions of your peers in this unique online setting. Again, we thank you for your participation and look forward to a lively and spirited discussion. In your participation on this panel, MedPanel expects and requires that you comply with the terms of the Consultant Confidentiality Agreement to which you previously agreed. If you have any questions about the terms of that agreement, please review them through the link provided on your MedPanel home page after you've logged in. |
Reading and posting instructions |
Identifying Icons: Questions are marked with a  . Important information is marked with a . Moderator questions are marked with  . Supporting Documents are marked with  . |
Q1: Diagnosing |
Currently how are your patients diagnosed with AAA? Do you currently screen for AAA? At what point do you decide to intervene? |
Panelist F: Patients are usuallly diagnosed with an abdominal ultrasound. A CT scan is used to define anatomy and suitablity for stent graft. Depending on patient's overall condition intervention is usually performed at 5 - 5.5 cm |
Panelist G: agreed |
Panelist E: Agree with both panelists |
Panelist G: Most are referred to me with the diagnosis. Some need repair, some are small and I follow them with US until 5 cm then CT to re-eval for endo options |
Panelist B: I ALSO RECEIVE REFERRALS FORM PCP |
Panelist E: The majority of my patients are diagnosed utilizing CT scan or ultrasound for an unrelated condition. I do screening for abdominal aortic aneurysms and all smoking males over the age of 65 and palpate the abdomen of all of my vascular patients. I consider surgical therapy when the aneurysm reaches five to 6 cm in diameter. |
Panelist H: We diagnose AAA with ultrasound and CT scan. We do screen for AAA. Depending on the patient, I intervene for AAA at 5.0- 5.5 cm. |
Panelist A: usually ultrasound or ct have arranged for medtronic sponsored aaa community screening projects twice - not good response from community encourage 1st degree relatives of my pts to get screened via their pcp's or to look in the newspaper for when lifeline will be in town generally intervene when >5cm, but involved with small aaa study and use clinical judgement for those unusually healthy or sick |
Panelist D: The screening is usually done by the family physicians. I mostly get patient referred after an icidental finding of a AAA, while a work up is being done for something else. Rarely a patient is screened specifically looking for a AAA. The exception is patients being worked up for a heart or lung transplant, in which case we always do screening abdominal ultrasounds. When I look for a AAA my typical test is a contrast enhanced CT scan. Once a AAA is found better definition and case planning is done with CT Angio and 3d reconstructions. |
Panelist D: Typically the decision points are rapid enlargement in size, size greater than twice the noraml aorta or more than 4.5 cms in women and more than 5 cms in men. Individual practice may vary, and with introduction of endoluminal repair, indications are being revised due to less morbidity. |
Panelist I: Currently the vast majority of my patients with AAA are found by either abdominal ultrasound or CT of either the chest or abdomen. In approximately 70%, the diagnoses is made incidentally. I do screen select patients with a family history of AAA and with risk factors such as smoking, HTN, COPD, HTN, Hyperlipidemia, etc. |
Panelist I: I typically intervene in patients with AAA size >= to 5cm or if there is a demonstrable increase in size of >5mm over a 6 month period. |
Panelist I: In some patients the aortic ratio of >2 to 1 can at times be applied as an indication for intervention especially in patients of smaller stature. |
Panelist B: We diagnose by duplex, CT and MRA |
Panelist B: WE DO SCREEN. DEPENDING UPON AGE IT IS AT >5CM. |
Q2: Current Treatment |
How do you currently treat patients with large (5.5 cm or larger) or fast-growing AAA? What treatment options are available, and how do you decide which treatment option to offer? |
Panelist F: Patients in this catagory would undergo repair of the aneurysm if they are candidates for repair. Options would include open surgical repair or endovascular repair. EVAR is primarily used in older patients or those with multiple co-morbidities. |
Panelist G: I will repair at this point if medically fit. I will do 1 mm cut CT to evaluate for endovascular repair. If not, proceed to open, usually retroperitoneal, repair. Decision against endo is usually based on quality of proximal neck |
Panelist E: I currently treat patients with abdominal aortic endografts or surgical repair. I individualize the treatment based upon the patient's anatomy and medical condition. |
Panelist H: Patients with AAA > 5.5 cm or rapidly expanding AAA's are treated with either an endograft or open repaire. I prefer to use endografts in anatomically approprite. |
Panelist A: usually endograft if decent infrarenal neck - suggest open aaa if young and healthy |
Panelist D: Once a decision is made to treat I decide whether the repair can be done endoluminally. If the anatomy is suitable I offer both open and endo repair to patient, and recommend one based on my judgement and experience and help the patient make the decision. We try to do most endoluminally unless the size is too big for current available devices, or neck is too short or no landing zones available. The endo device we use exclusively is Gore Excluder bifurcated or tube grafts. We have some experience with the Anue RX and Endolgix devices also but prefer Gore. The open procedure usually uses a Gore PTFE tube or bifurcated graft usually 8 mm. Older sicker patients are preferentially offered endoluminal repair. Yonger healthier ones are steered moe towards open repairs. The available sizes of endoluminal devices are the major limiter of choice in using endo repair. |
Panelist I: At this point surgical intervention is indicated. Traditional versus endovascular repair is then carefully discussed with the patient. A CTA with reconstructions is then obtained and the option for endovascular repair is discussed with the patient. The recommendation for treatment options is generally based on the patient's age and comorbidities. In most cases, an endovascular approach is recommended. |
Panelist B: I TREAT WITH OPEN OR STENT GRAFTS DEPENDING UPON ANATOMY AND PT DECISION |
Q3: Open Versus Endovascular |
Considering the two approaches: - Open-chest or abdominal surgery
- Endovascular aneurysm repair (EVAR)?
Please explain which approach you prefer and why. When (what type of patient or condition) does it make sense to use one versus the other? Do you believe there are any significant benefits, from either the patient or physician standpoint, with open surgical repair in comparison to EVAR? Do you believe there are any significant benefits, from either the patient or physician standpoint, with EVAR? Please explain. |
Panelist G: I don't prefer one over the other...decision is purely based upon patient anatomy. I will now offer EVAR even to younger patients provided anatomy is propper (excluding Marfan's patients. Clearly patients treated with EVAR will leave the hospital sooner and perhaps experience lower morbidity and death rates...but is is close. I don't loose many open cases either...even though they often have unfavorable and risky anatomy. |
Panelist E: If it is an older patient with multiple comorbidities I will proceed with an endovascular repair if it all possible. If it is a very young patient (50 to 60 years of age) with a very straightforward aneurysm repair, I will proceed with an open operations. The main determinant of endovascular repair is a suitable proximal neck which is being expanded with regards to treatment options due to the new grafts being put out on the market |
Panelist E: With regards to patient benefit, there is no question that the postoperative course is much easier however our trials have not shown a distinct mortality advantage with regards to endovascular repair. |
Panelist H: I prefer to use EVAR in anatomically appropriate. In a patient with significant cardiopulmonary comorbidities, I would certainly prefer to use EVAR. Clearly postoperative recovery after EVAR is much easier than after open repair. |
Panelist A: generally prefer endo aaa to open aaa - do not have experience with thoracic work evar is such a smaller hit to patient, that only suggest open if young and healthy once open aaa is done and recovered, not much chance of long term problems, but if endo aaa's selected well, they also do well long term (i.e. don't do short tortuous necks) |
Panelist D: Open repair obviously takes loniger anesthesia, and prolonged post op recovery. More pain and more physical demand on the patient. on the other hand open repair is more durable, less incidence of endoleaks and time tested long term results. Endo repair avoids risk of bowel injury, bladder or ureter injury etc. Very weak, old , ovbese COPD, heart disease patients or those with multiple previous abdominal surgeries would be likely to get endoluminal reapair. Younger, healthier, strong lungs, no heart disease, no previous abdomial surgery patients woould likely get open repair. Endo repair has less ICU and hospital stay. Endo repair is not for every one. Less patients are candidates for endo repair than open repair. Very large and very long aneurysms are open repair candidates. |
Panelist I: I prefer EVAR for the following reasons, 1. Enhanced recovery time and faster return to normal activity for the patient. 2. Decreased hospital stay. 3. Decreased 30 day morbidity, mortality. 4. Technically more facile approach. 5. Patient satisfaction and request. The benefits for EVAR are as stated above. The only benefit for traditional/open repair would be to avoid the post op surveillance CTAs the patient is required to have post EVAR. |
Panelist B: IF THE PT IS YOUNG, <65 AND IN GOOD HEALTH I RECOMMEDN OPEN REPAIR AS IT IS MORE DURABLE. IF OLDER OR OF POOR HEALTH I PREFER EVAR. CERTAINLY EVAR IS EASIER TO RECOVER FROM BUT THE LONG TERM FOLLOW-UP COSTS ARE A CONCERN FOR SOME PTS |
Q4: Awareness and Use of Endovascular Stent Products |
What specific endovascular stent systems are you aware of? Which ones do you use and why? Please specify device brands and/or manufacturers. |
Panelist G: AAA: Excluder, Aneuryx, Zenith, Powerlink TAA: Excluder TAG, Talent, Valient, Bolton Relay, Zenith. I use all but prefer Gore |
Panelist E: I currently use the Cook and Gore grafts. I do not currently use the Endologix and Aneurx grafts. I like to use the Cook graft due to its proximal fixation and large diameter proximal neck. I use the Gore grafts due to the ease of placement and straightforward aneurysms. |
Panelist H: We mainly use Aneuryx grafts by Medronics. However, we have also implanted the Gore Excluder as well as the Cook Zenith graft. The Aneuryx graft appears to have the best tract record. |
Panelist A: i think i am aware of them all i use zenith currently used medtronic most of my endo aaa career but started using zenith for the wider necks and got to like it never liked the quick release method of gore (i am slow at deploying, usually taking multiple picures during the deployment) tried endologix when it was being developed in arizona and liked it, but after released my partner tried it and it did not go well so i never pursued it (not a good reason, but once you get used to a system i did not feel compelled to change) |
Panelist D: Gore excluder is the device we prefer to use. The device is easy to use. Easy to deliver. Comes in practical sizes and the rep. is very k nowlesgeable and helpful. The AneuRX and Endologix systems offer some variations for unique circumstances and have certain advantages, but our experince with Gore is very satisfactory with low incidence of stent migration and endoleaks. Gore, Medtronics and St. Jude are the main market heavies. |
Panelist B: OUR CURRENT PREFERENCE IS THE GORE EXCLUDER. ENDOLOGICS AND ZENITH ARE ALSO USED. |
Panelist B: BOTH OF GORE AND ENDOLOGIX ARE EASIER TO USE. |
Q5: Comparison of Stent Products |
Please compare the following product systems, indicating the strengths and weaknesses of each: - Medtronic’s AneuRx Stent Graft System
- W.L. Gore & Associates’ GORE EXCLUDER Endoprosthesis, Bifurcated GORE-TEX Stretch Vascular Graft
- Cook’s Zenith AAA Endovascular Graft, RENU AAA Ancilliary Graft, Fenestrated AAA Endovascular Graft
- Boston Scientific’s Hemashield Gold Microvel Knitted Double Velour; Hemashield Platinum Woven Vascular Grafts
|
Panelist G: Medtronic leaks through needle pops and is difficult to deploy, on the other hand, it is accurate. Gore does not leak and new low-perm model invites significant sac shrinkage. Very easy to deploy, amenable to percutaneous deployment...on the other hand, it may not be as accurate in inexperienced hands Cook has large diameters, suprarenal fixation and fenestrated options. Not as easy as Gore to deploy Open Dacron vs ePTFE grafts...do major differnces |
Panelist E: I would have to agree on all accounts with panelists G. The Cook graft is more difficult to deploy but once fixated in the neck it is very secure. The Gore graft will allow for percutaneous placement in select cases however accurate placement is difficult in compromised aortic necks. The iliac glands however are much easier to maneuver through tortuous and stenotic arteries. |
Panelist E: I have not used the Medtronic graft in a significant time and therefore would not be able to sufficiently comment on this graft. Gore: ease of use and ability to navigate tortuous arteries Cook: with the new ancillary graft and upcoming fenestrated graft, this will likely be able to treat the highest number of aortic aneurysms in the future. Open surgical grafts: do not find a significant advantage to one versus the other |
Panelist H: The AneuRx graft has very good columnar strength to prevent graft migration. It also has the longest tract record and most grafts implanted worldwide. The Gore excluder benefits from ease of delivery. The Zenith graft benefits from suprarenal fixation and ability to be utilized for large necks. The Hemashield Knitted graft is excellent for open cases. It is our graft of choice for open cases. |
Panelist A: a. quick and easy, but can slip if tortuous neck b. see q4 answer c. see q4 about zenith, don't have experience with renu or fenestrated d. used hemashield for opens ever since trials at mayo in 1988, though also like gore for opens if size or shape mismatch |
Panelist D: Gore excluder is the device we prefer to use. The device is easy to use. Easy to deliver. Comes in practical sizes and the rep. is very k nowledgeable and helpful. I have been trained on the AneuRx system. Has a nice delivery system, and certain feature which are nicer than Gore, but in our center we have had a too many stent migrations so we prefer to use Gore. We have not used Zentih system. The BS Hemashield Doubel Velour woven grafts are the ones we use for all open repair. The platinum is less porous but comes in very limited sizes. I would prefer to use the platinum for any open repair. |
Panelist B: A. MEDTRONIC IS SOMEWHAT CUMBERSOME WITH ITS DEPLOYMENT MECHANISM. B. GORE IS VERY NICE AND SIMPLE AND BASED UPON IT'S VIABAHN STENT GRAFT. C. I DO NOT LIKE THE ZENITH BECAUSE OF ITS HARDWAE TRAVERSING THE RENALS D. ALL OF THESE GRAFT HANDLE WELL AND I SEE NO ADVANTAGE OF ONE OVER THE OTHER. |
Q6: Stent Products |
What factor would be most important in increasing the number of patients you treat using EVAR (increased clinical data supporting technology, increased patient referrals, lower device cost, better products, other)? |
Panelist G: Nothing really, we have hit our max. Maybe fenestration and maybe rivets, but again, maybe not |
Panelist E: Identifying increased number of patients with aneurysms greater than 5 cm in diameter or a clinical trial documenting the benefit of treating small abdominal aortic aneurysms. Improved technology will also allow us to treat almost all aneurysms in an endovascular fashion in the near future. |
Panelist H: The factor that would increase the number of patients treated with EVAR would be technically improving the grafts to allow for more variable patient anatomy(ie. tortuosity of vessels, short neck, tortuous neck, ect.) |
Panelist A: match to more anatomy |
Panelist D: I think the increase in patient referral, avaialability of more size ranges and the availability of fenestrated and branches grafts would increase my use of all endo devices. Smaller delivery systems would also help. Cost is no concern to me, as most insurance companies pay the hospital and physician fees. |
Panelist B: THE COSTS ARE EXCESSIVE FOR ONE THING. ALSO MORE CONVINCEING PUBLISHED DATA THAT THIS IS THE PRIMARY WAY TO GO. ALSO SMALLER PROFILES ARE NEEDED. |
Click here to review product profile |
Q7: Awareness |
Prior to this study, what did you know about Endologix’s PowerLink system, and what was the source of your awareness? |
Panelist G: I have used it |
Panelist E: I knew about the graft from the representative of the company and was familiar with the graft design |
Panelist H: I have not placed this graft |
Panelist A: see q4 |
Panelist D: I am aware of the endologix system. I met with the rep and got trained on the model and system. I am scheduled to go to a training course in Orlando next week. I think it offers unique advantage in patients with a compromised access from one vessel. It does require some extra steps but it may the solution to some patients who would not be candidates for other systems. |
Panelist B: YES. I HAVE USED IT IN THE EARLY STAGES. |
Q8: Reaction to Profile |
How does this product compare to the others on the market and the others that you use (if you are not a PowerLink user)? What are this product’s greatest strengths and weaknesses? |
Panelist G: I have used it and don't buy the profile. It is hard to use and the endoskeleton catches wires and catheters. Since there is no durability advantage, I won't likely use it again |
Panelist E: Strengths compared to previous products: may be the ability to avoid a second incision. Weaknesses: offers no advantages to the grafts that I currently use |
Panelist H: No experience |
Panelist H: Probably does not provide any significant advantage |
Panelist A: not supra renal fixation - which is bad good technology improvement from the ancure graft for getting up and over without twisting wire - good cardiologists who use a poor old cardiac surgeon to do their cut downs will like it so they can poke on side while the surgeon cuts the other - good (if you are a cardiologist) |
Panelist D: I think it offers unique advantage in patients with a compromised access from one vessel. It does require some extra steps but it may the solution to some patients who would not be candidates for other systems. |
Panelist B: YES, A STANDARD UNIBODY DESIGN. |
Q9: Likely Use of PowerLink for AAA |
Considering the profile you’ve just reviewed, please discuss how likely you are to use the PowerLink stent graft over other specific products (for both endovascular and open-chest/abdominal grafting). |
Panelist G: unlikely |
Panelist E: Will not likely use the product as I'm happy with the other two products that I utilize |
Panelist H: I am pleased with our current array of grafts. Thus, unless data demonstates this system to be superior to the others, I would probably not use it. |
Panelist A: not planning to use |
Panelist D: I dont see the use of this device in any open chest cases. I do think there are some patients out there who would only be candidates for endo repair if they can be accessed from one side with a larger French sheath. Those who have had vascular bypass procedures in the past. I will have more to say about is after next week after I come back from the training course. |
Panelist B: NO MORE LIKELY THAN BEFORE BUT ONLY FOR EVAR. |
Q10: A one piece system |
Do you believe there are any significant clinical benefits to Powerlinks unique single piece design and delivery mechanism? How important to you is the fact that it’s a one piece system? What are the benefits you would see versus current systems (time savings, error rate, etc.)? |
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