Inclusion Criteria

• Board-certified or eligible electrophysiologist
• In practice between 2 and 30 years
• Spends at least 75% of professional time in clinical practice
• Performs at least 10 ICD implants per month

Physician

Location

State

Mark Delegge, MD

Medical University of South Carolina

SC

Anthony Kalloo, MD

Johns Hopkins University

MD

Michael Kochman, MD

University of Pennsylvania

PA

Karl LeBlanc, MD

Vista Surgical Center

LA

Julian Losanoff, MD

Wayne State University

MI

Roger Mendis, MD

New York Hospital Queens

NY

Carlos Pellegrini, MD

University of Washington

WA

Richard Sampliner, MD

University of Arizona

AZ

Bruce Schirmer, MD

University of Virginia

VA

Lee Swanstrom, MD

Oregon Health Sciences University

OR

Question

Pages

Q1: About NOTES

When and how did you first hear of NOTES? Where do you currently find up-to-date information about it? What is your impression of this surgical approach?

5

Q2: Benefits of NOTES

What do you perceive to be the potential benefits of NOTES and why?

6

Q3: Concerns about NOTES

What do you perceive to be the potential risks associated with NOTES? Why do you say this?

7

Q4: Suturing

After reviewing the attached abstract, please share your opinions about this technique. On a scale from 1 to 5, with 1 indicating “very easy” and 5 indicating “very difficult”, please rate the degree of difficulty of the suturing technique described. Would you expect the technique discussed in the abstract to be widely adopted? Why or why not? How does it compare to suturing techniques in other endoscopic and/or laparoscopic procedures? Are there other potential means through which tissue can be approximated in NOTES procedures?

10

Q5: Hemostasis

Please review the attached abstract. On a scale from 1 to 5, with 1 indicating “very easy” and 5 indicating “very difficult”, please rate the degree of difficulty of using these devices. How do they compare to devices used for hemostasis in current endoscopic and/or laparoscopic procedures? Are there other techniques or devices utilized for hemostasis in these procedures that can be adapted for NOTES? Are you aware of other devices that are currently in development for hemostasis in NOTES?

10

Q6: Traction and Counter-traction

After reviewing the attached abstract, please share your opinions about this technique. On a scale from 1 – 5, with 1 = very easy and 5 = very difficult, please rate the degree of difficulty of the technique. Are there other uses for magnets in NOTES? Are magnets used regularly in other surgical or GI procedures? What risks might be associated with the use of magnets in the NOTES approach?

11

Q7: Transluminal closure

After reviewing the attached abstracts, please share your opinions about these techniques. Which methods do you think will be most effective for transluminal closure? Are there different techniques that would be more appropriate for different approaches? What other methods of transluminal closure not discussed in these abstracts might be appropriate for NOTES?

12

Q8: NOTES equipment/platform

Imagine that you were asked to develop the ‘ideal’ surgical platform through which a NOTES procedure could be performed. What attributes of the platform would be the most critical? In consideration of the surgical and endoscopic tools that are currently available, what equipment do you think is most important to develop? As you respond here, please keep in mind the approaches to suturing, hemostasis, traction, and transluminal closure that have been discussed, but feel free comment on other aspects of the NOTES approach that have not been addressed.

13

Q9: NOTES procedures

There have been reports of the NOTES approach being utilized to perform cholecystectomy, gastrojejunostomy, splenectomy, tubal ligation, and oophorectomy in animal models. There have also been reports of appendectomies and cholecystectomies being performed in humans via NOTES. The attached abstracts detail a NOTES approach for a distal pancreatectomy and a right colectomy in animal models. Which surgeries do you think are most amenable to a NOTES approach and why? What learnings from the introduction of laparoscopic surgery can be applied to current experiences with NOTES?

13

Q10: Incorporation of NOTES into practice

How applicable do you think NOTES is to your field? Do you think it will be adopted by you and your colleagues? If so, what needs to be done in order to facilitate a smooth transition into your field of practice? If not, what do you think the primary concerns might be?

16

Q11: Role of industry

What do you perceive to be the level of interest among device makers to develop the equipment necessary for NOTES? Which companies are currently involved in this arena and what are they developing? Which manufacturers should be involved in the development of this technology? How, if at all, does the NOTES ‘community’ try to engage industry in addressing unmet needs related to the approach? Do you expect efforts in this regard to increase going forward?

18

Introduction

Hello and welcome to Panel Intelligence. We thank you for joining this special discussion among opinion-leading specialists including gastroenterologists and general surgeons. Our goal of this panel is to discuss some of the latest data and information emerging from this year’s Digestive Disease Week conference about natural orifice translumenal endoscopic surgery (NOTES). Along the way, you may be asked to consider certain questions and issues from a variety of perspectives, including those of clinicians, researchers, and industry. 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, Panel Intelligence 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 Panel Intelligence home page after you've logged in.

Q1: About NOTES

When and how did you first hear of NOTES? Where do you currently find up-to-date information about it? What is your impression of this surgical approach?

Panelist 3: I learned about it from meetings with the ASGE

Panelist 1: First heard about when discussion of Reddy and Rao and Kallo first surfaced...I find information form discussion with other researchers, reading, and consulting. I am not sure if it is entirely correct to categorize this as a surgical approach - that wording carries with it connotations. This impression is that it has some merit and is in search of applications...

Panelist 10: I first heard about it a year or two ago. I have seen some of the prototypes of instrumentation at meetings such as SAGES, ACS and ASGS. I think that this approach is a combination of endoscopy and surgery. It is a technology that will be slow in developing in widespread use. Currently, industry is driving hard to be the first in.

Panelist 4: 1997 DDW presentation, information can be obtained on www.noscar.org and Medline searches. I believe this to be the future of surgery

Panelist 11: First heard about NOTES at the ACG meeting in Hawaii Oct 2005, but ACG meeting in Las Vegas, fall 2006, there was a very stimulating presentation by Dr. Anthony Kalloo.

Panelist 12: Can't remember when I first heard about NOTES. Probably two to three years ago at a SAGES meeting of some sort. Impression is that it is an interesting concept, with potential application. Needs to have full proof access/infection issues resolved before it has a chance.

Panelist 7: on research committee about 2 years ago

Panelist 7: in literature, in emails from GI societies

Panelist 6: Our research project started in 2004 as an extension of our EMR/perforation work. I am fairly involved in the NOTES community so here a lot from the meetings I am invited to and from my collaborators. Also, industry is around a lot as we do a lot of NOTES in our lab. Obviously I am a big supporter of the NOTES concept and love to see this level of interest

Panelist 5: First heard about it shortly after Rao reported a case. Have been involved ever since looking for papers, attending meetings and discussions. Believe that this may be a future for some areas of gastrointestinal surgery but also believe this is unlikely to completely replace current approaches

Panelist 9: Read about it in several papers. Very impressive, although the literature on it does not provide a clear perspective.

Q2: Benefits of NOTES

What do you perceive to be the potential benefits of NOTES and why?

Panelist 3: Least invasive surgical-like procedure. natural orifice

Panelist 1: The potential for this to be a less-invasive procedure and to offer solutions that we have not dreamed to be possible.

Panelist 10: I agree with Panelist 1. It would be scarless surgery with the potential with ever diminished recovery rates.

Panelist 4: no scars, less pain. Maybe the best approach to peritoneal cavity in the obese patient. Has the ability to do peritoneal surgery in a non operating room environment

Panelist 11: An extension of minimally invasive surgery or maximally invasive endoscopy, depending on your perspective! Overall, expect more will be able to be done with less pain, fewer hospital days and shorter recovery period.

Panelist 12: Elimination of abdominal wall trauma. Extraction of tumors with less chance of abdominal wall contamination.

Panelist 7: no external scars, potentially easier access to some sites

Panelist 6: Possibly: less pain shorter hospital stay less immunosuppression better cosmesis

Panelist 5: I believe there may be certain benefits of this approach, but certainly disagree with panelist 3 that this is the least invasive approach. In its current stand it is much more invasive than laparoscopy. I believe it may have a benefit once appropriate instrumentation is developed to perform operations on the abdominal wall (like ventral hernia repairs) which currently require entry AND REPAIR from the same site. It may also have specific application in areas of the world where we do not have developed operating rooms, if the equipment is compact and the operations can be done in a non-sterile environment. I am not convinced the obese will be helped with this approach.

NOTES in patients with obesity

There have been comments both in support of and questioning the potential utility of NOTES to access the peritoneal cavity in patients with obesity. Please describe the strengths and limitations of using NOTES in this population. Do you think NOTES will offer a significant benefit to patients with obesity?

Panelist 1: In favor would be the potential for a lower cardiopulmonary risk profile...against would be issues with exposure and the management of complications in this population, already quite difficult. Overall I believe that it may be of benefit, though the replication of a HALGB will be quite difficult to perform repeatedly

Panelist 6: I don't see any particular advantage over laparoscopy in the obese. Less invasive bariatric surgery remains a desirable goal.

Panelist 5: While in theory access through a natural orifice should simplify this type of patient's operation I think navigating through an obese patient and finding adequate exposure is going to be much more difficult

Panelist 9: I do not see what the benefit is. Actually morbid obesity can be considered a relative contraindication for NOTES.

Panelist 4: There is data to support this comment. The laboratory data thus far suggest the opposite. Both gastric restriction and gastrojeunostomy have been successfully performed despite the rudimentary equipment

Panelist 11: Yes, beneficial in reducing wound dehiscence, potential side effects of would complications in this population, maybe reduce recovery time.

Panelist 9: Less invasive, the expected recovery is shorter. However, more experience is required to provide reliable info about the potential morbidity.

Panelist 12: NOTES has even greater potential value in the obese than in the average weight patient. Abdominal wall access and issues will be avoided. We have already seen with laparoscopy that the biggest beneficiaries of it are obese patients in all types of operations.

Q3: Concerns about NOTES

What do you perceive to be the potential risks associated with NOTES? Why do you say this?

Panelist 3: Maintaining sterility of procedure, adequate gastric closure and adequate training for gastroenterologists. Also, the interaction between surgery and GI

Panelist 1: The main concerns about the concept include the ability to maintain certain of the surgical tenants and to maintain a low infection rate and adequate anastomses and closure techniques. Beyond that there are issues concerning targets and management of procedural complications including hemorrhage. The major risk is that it will not be viable financially for the practitioner and also for the companies in terms of device development

Panelist 10: Infection, higher complication rates early on. A significant learning curve. Attempts by individuals that do not possess the skills to do such procedures with inadequate training.

Panelist 4: the potential risks are those of any surgical intervention in the peritoneal cavity. there may be physiological risks that are unknown but much work is currently be done in this area

Panelist 11: Few human trial (none that I am aware of) to document efficacy and safety.

Panelist 7: contamination from oral flora

Panelist 6: introduces possibility of enteric leak and peritoneal contamination. Biggest risk may simply be from ill prepared surgeons plunging into this without preparation and wrecking all sorts of havoc

Panelist 5: a) Closure of the colon, vagina or stomach (failure of) with its attendant complications. b) Have current gastroenterologists that practice interventions (ERCP, Liver Bx etc) start performing operations without appropriate knowledge of preoperative preparation and post operative care for abdominal operations. They are used to just do procedures without pre or postoperative knowledge/care. c)Lack of appropriate instruments and visualization techniques that may result in decreased safety at the target (appendix, gallbladder area, etc

Potential barriers to NOTES

The White Paper published by the ASGE/SAGES working group on NOTES published in 2006 lists the following as potential barriers to clinical practice: • Access to peritoneal cavity • Gastric (intestinal) closure • Prevention of infection • Development of suturing device • Development of anastomotic (nonsuturing) device • Spatial orientation • Development of a multitasking platform to accomplish procedures • Control of intraperitoneal hemorrhage • Management of iatrogenic intraperitoneal complications • Physiologic untoward events • Compression syndromes • Training other providers Other concerns that have been described about NOTES include: • Manipulation of internal organs • Locating the optimal point of access to peritoneum or comparing transgastric access to other approaches including trans anal/colonic, cystoscopic and transvaginal • Closure of transvaginal or cystoscopic access sites • Working channels limit the size of instruments • Need to develop appropriate equipment Are there any other concerns not mentioned? Which do you think are the five most significant concerns about NOTES and why?

Panelist 1: see below

Panelist 6: Accessing the technology that is out there and bringing it all together - there are good platforms and tools now but from different companies. Lots of political questions: reimbursement, credentialing, malpractice.

Panelist 5: I think you have covered most with the White Paper. To me the key issue is whether the secure closure of a viscus can ever be achieved, or compared with the relative impunity of putting a trocar through the abdominal wall.

Panelist 4: putting a trochar through the abdominal wall is not an impunity

Panelist 9: Obesity and adhesions

Panelist 11: Access to peritoneal cavity • Gastric (intestinal) closure 5 most important: • Development of anastomotic (nonsuturing) device • Development of a multitasking platform to accomplish procedures • Control of intraperitoneal hemorrhage • Management of iatrogenic intraperitoneal complications • Training other providers

Panelist 12: None beyond what mentioned. But I think the manipulating internal organs has several ramifications of problems: bringing two organs together that are apart will be difficult with one scope. Also, manipulating organs without damaging them using the scope while still being able to see and maintain visual field will be difficult. Five most difficult: all are in contention but Closure, control of bleeding, iatrogenic injury, stable platform for multitasking, and organ manipulation seem toughest.

Financial risk

One panelist wrote that “the major risk is that it will not be viable financially for the practitioner and also for the companies in terms of device development.” Do you agree with this perspective? Is there something particular about NOTES that drives this concern compared to other surgical or endoscopic techniques?

Panelist 1: see prior response, the system did not log it.

Panelist 6: it is unknown if it will apply to high volume cases or rare esoteric ones. If the later, there will be less money to invest.

Panelist 5: I think this is a typical statement from a group of physicians trying to advance their own cause, and assuring that they say so in a politically correct fashion, ie., "the patients are concerned" that we physicians are not going to be adequately reimbursed. Nothing could be more selfish. Physicians make a lot of money, more than most patients we treat, and patients have no sympathy for our "reimbursement". If we physicians can bring VALUE to the patient with the addition of NOTES - and that is far from being clear at this time - the system will see to it that we get reimbursed.

Panelist 9: I do not have major concerns about this. In the short run, yes, similar to laparoscopic surgery in the early 90s. As time4 elapses and the experience grows, NOTES will be offered by most major institutions.

Panelist 4: With new unproved endeavor there is a risk. NOTES is a paradigm shift and goes against basic principles in which we were trained i.e. a perforation is a terrible complication. It should not be surprising that this endeavor causes anxiety and caution.

Panelist 11: Hoping patient outcomes and not financial risks drive the technology

Panelist 12: Probably do not agree with this concern. The concern probably stems from the fact that traditionally endoscopic procedures reimburse less than operative procedures such as laparoscopic or open laparotomy. If current reimbursement rates for flexible upper and lower diagnostic scopes are used as basis for NOTES reimbursement, this will be a problem. But for the practitioner, not the manufacturer. The manufacturer can make a profit based on charges for the equipment, which are almost always borne by the facility and reimbursed by insurance unless the facility has a comprehensive package with a cost lid.

Panelist 1: infection, conversion to open procedure in a patient with a potentially unreasonable expectations, need for effective devices, demonstrated outcomes, too much testosterone and need to leave a mark from the groups who wish to be competitive from a marketing perspective - the academic groups need to perform advancement and dissemination in a rational way

Panelist 1: meant for this to be under potential barriers

Panelist 1: The current financial environment where time is money and therefore foregone opportunity, needs to be recognized. The health systems are becoming ROI based for purchasing, OR time costs money, and the overall expenses including complications need to be managed carefully. Of course, if we learn from the cosmetic dermatologists and the eye surgeons, we will invent our procedures that are patient desired and outside of traditional reimbursement/insurance coverage. :)

Panelist 9: I think that the learning curve in NOTES is expected to be longer than in laparoscopic surgery. NOTES requires large previous experience in laparoscopic surgery.

Panelist 12: Major risks include peritoneal contamination from intraluminal leakage, especially from poorly closed access sites. Also, imagine operating on areas of previous surgery will be even more risky with NOTES than with laparoscopic surgery.

Panelist 12: Risks of NOTES are well given in the list. See below for potential barriers question.

Click here to review abstract about suturing

Q4: Suturing

After reviewing the attached abstract, please share your opinions about this technique. On a scale from 1 to 5, with 1 indicating “very easy” and 5 indicating “very difficult”, please rate the degree of difficulty of the suturing technique described. Would you expect the technique discussed in the abstract to be widely adopted? Why or why not? How does it compare to suturing techniques in other endoscopic and/or laparoscopic procedures? Are there other potential means through which tissue can be approximated in NOTES procedures?

Panelist 1: This an apparently cumbersome technique, though it appears to be effective in that it replicates proven techniques of knot tying. I would rate it a 4.5 for speed and complicated technique. I doubt that it would be widely adopted as it requires time, facility, and is tied to a dedicated platform.

Panelist 10: It appears difficult, however, like many new procedures, it will probably be modified in the future. There are other techniques with different instruments currently in development that allow suturing.

Panelist 5: This is very cumbersome technique as described. It will have to be a more automated type of suture technique before it can be applied in a more general fashion. I give it a 4 in the scale of complexity

Panelist 4: Currently this is a 5 but is really dependent on what devices can be developed by industry. With a simple device this will be a "homerun"

Panelist 11: Seems to be effective method, with some difficulty (3). Would look for other simpler methods before adopting

Panelist 3: I would say a 4. As described it seems cumbersome. However, the multi-channel platform has a good future.

Panelist 12: Sounds like at least a 4 at this time. Does not seem to be amenable to any tactile or perhaps even instrument feedback as to adequate pressure on the knot. Visual feedback only. It will be adopted only by the dedicated and patient. There will be a better way by some mechanistic invention.

Panelist 7: sounds like it is for surgically trained docs

Panelist 6: difficulty: 4 This is a bit of a "trick" just pushing the limits of current devices. It would not be a practical everyday solution because of difficulty maintaining tension etc. There are many other tissue closure technologies out there now that make this easier including triangulating tip endoscopes that allow intracorporial suturing.

Panelist 9: Very difficult. The future belongs to the technically advanced clipping and stapling methods.

Click here to review abstract about hemostasis

Q5: Hemostasis

Please review the attached abstract. On a scale from 1 to 5, with 1 indicating “very easy” and 5 indicating “very difficult”, please rate the degree of difficulty of using these devices. How do they compare to devices used for hemostasis in current endoscopic and/or laparoscopic procedures? Are there other techniques or devices utilized for hemostasis in these procedures that can be adapted for NOTES? Are you aware of other devices that are currently in development for hemostasis in NOTES?

Panelist 1: This in comparison to the suturing appears to be easier and is building upon technology that is familiar to both GI and surgeons alike. I would rate it a 1. This is likely to be adopted as it also has non-NOTES applications and can be justified for purchase by many more than the NOTES aficionados.

Panelist 6: very comparable to current laparoscopic technology and many times better than is currently available for flex endo. I rate it a 2. Only thing better would be technology to co-apt and divide at the same time (like the ultrasonic scissors in laparoscopy) There is not a lot of development effort happening in the energy source arena as most of this would not be patentable.

Panelist 10: Appears to be a 1. Compares favorably to the others that are available and I also agree, that this may be adapted to non-NOTES procedures.

Panelist 4: 1-2, can be performed by current endoscopic devices

Panelist 3: This appears to be much more practical than knot tying

Panelist 3: I would give it a 2

Panelist 12: Agree with panelists so far in that this seems to be a 1 or 2 and relatively straight forward.

Panelist 7: 1-2, look good for endoscopic techniques as well as NOTES

Panelist 6: NOTES is an endoscopic procedure

Panelist 6: rate it a 2. much needed for endoscopy and replicates what we use for laparoscopy

Panelist 5: I think as described it is a 1 in difficulty, it looks similar to the currently used techniques and it should be useful. A 100% record of achieving hemostasis is a very good one.

Panelist 9: Very easy, but not very reliable for arterial hemostasis if the vessel is larger. Clipping or stapling carries the expectation of a lower morbidity and mortality.

Panelist 11: 2. Appear reasonably easy to use and are similar to current endo thermal devices.

Click here to review abstract about traction

Q6: Traction and Counter-traction

After reviewing the attached abstract, please share your opinions about this technique. On a scale from 1 – 5, with 1 = very easy and 5 = very difficult, please rate the degree of difficulty of the technique. Are there other uses for magnets in NOTES? Are magnets used regularly in other surgical or GI procedures? What risks might be associated with the use of magnets in the NOTES approach?

Panelist 1: It does not appear to be difficult and I would rate it a 2. I do not believe that it will be adopted due to issues that are not yet discussed: effects on other equipment, and the need to affix additional objects. The ability to place flat polymers or biosynthetic materials will occur by other methods as the delivery and handling of the material is the issue. It can be positioned and affixed by other methods. Magnets may have some use in NOTES but I doubt widespread adoption. They have been used for enteric anastomosis.

Panelist 10: I rate at 2.25. The use of magnets may prove to be helpful but I suspect that other methods will supersede them. One risk with their use could be the loss of it and the inability to retrieve it, predisposing to infection and operation.

Panelist 4: 3-4 may not be as necessary for NOTES. magnets are a neat way to do this

Panelist 3: I would give this a 3.5. I don't think this is how it will ultimately be done. Magnets, to date, have not been our friends in complex endoscopic procedures

Panelist 7: can not see abstract