BB&TContributing Writer

LOS ANGELES — Insights into the future of surgery were presented here at the 20th anniversary of the Society of Laparoendoscopic Surgeons (SLS; Miami) annual meeting. Predictions on telementoring guidance, single port surgery vs. NOTES, robotic surgery, ablative therapies, and even the elimination of general anesthesia in select cases were debated among the general, gynecological, urological, foregut surgeons and endoscopists attending this conference.

Telementoring guidance

In the opening ceremony, James “Butch“ Rosser, Jr., MD, President of SLS, Chief of Minimally Invasive Surgery at Beth Israel Medical Center (New York) coined the term “edutainment“ to describe the format for this year's meeting; as he delivered an entertaining form of education with many interactive events, town hall meeting formats for controversial issues, and his now famous “Top Gun“ laparoscopic skills shoot out contest. Rosser addressed the audience of advanced laparoscopic surgeons and endoscopists by telling them that in his book SLS stands for the Society of the League of extraordinary Surgeons because members of this society are the promoters and early adopters of advanced surgery.

Rosser is known internationally as a pioneer who has likened video games to laparoscopic skills and has pioneered telementoring guidance as a form of directing a surgeon from a distance. Telementoring is much like using Skype, where the experienced surgeon is watching a remote surgery being performed in real time by the less experienced surgeon who is doing the surgery in a distant place while listening to the mentor from afar walk him through the procedure.

Until now the hurdle to widespread use of telementoring has been a medical-legal one, where licensure across state boundaries along with lack of malpractice coverage has been a huge barrier. At this meeting, Rosser announced that for the first time ever “one of our members“ would now be offering a medical malpractice coverage on an episodic basis for telementoring guidance. In addition, all states will provide a temporary medical license. The combination of licensure and temporary interstate malpractice coverage will now provide a higher degree of confidence for surgeons to employ telementoring guidance.

“Not only is this important to the surgeons residing in the 50 United States, but also to the over 40 countries represented at this meeting that has now become an international meeting. Representatives from Australia, Russia, Serbia, Singapore, South Africa, Spain, Switzerland, UK, Nepal and 31 other countries are in attendance here and now have telementoring available to them,“ said Rosser. “Traditional laparoscopy is broken. There are too many complications and not enough adopters of advanced techniques. Telementoring's time has come. The time has come where no surgeon should operate alone,“ he added. (See Table 1)

Table 1

Methodology of Telementoring

• Pre-procedural assessment and enhancement of laparoscopic surgical skills

• Computer-based instruction

• Military like two-way communication

• Establish a standardized technique algorithm

• Familiarization with teleguidance tools

• Telementoring simulation

Source: Butch Rosser, MD, Presidential address, SLS opening speech

Single port surgery vs. NOTES

“We need to stop being either a NOTES (Natural Orifice TransEndoscopic Surgery) or single port (laparoscopic surgery done through the umbilicus) purist and bring them all together to attain the next level of minimal access surgery,“ opened Paul Curcillo II, MD, Director, Minimally Invasive Surgical Initiatives and Development, Fox Chase Cancer Center (Philadelphia) in the master's class for Reduced Port Minimally Invasive Surgery (MIS) aptly titled “More than an Incision Decision.“ “With this new rebirth of reduced port techniques, we need to stay focused on techniques and not products; along with attention towards safety, outcomes, and cost effectiveness,“ Curcillo continued, “Reduced port surgical techniques will take us to the next level of minimal access surgery whether it is NOTES, single port, a combination, or something beyond. NOTES let us realize we could push our limits.“

Table 2

Patient Benefits of Single Port or NOTES Surgery

• Scarless

• Less pain

• Faster return to normal activities

• Possible to avoid general anesthesia in select cases

• Comparable length of stay in hospital to conventional laparscopy

• Comparable outcomes

Source: BB&T notes from SLS seminars, Industry contacts

While understanding that reducing the number of holes made into the abdomen can benefit patients (See Table 2), Curcillo emphasized the importance of measuring the risk vs. benefit when making decisions for the procedure being done on a patient. His SPA concept is based on how multiport surgery can be mimicked into a single hole, but not at the expense of patient safety. “It is far better to add an additional hole, or use an additional NOTES entry than to risk the safety of the patient,“ he admonished.

So far, only 15% of all laparoscopic procedures are performed using a single port. It is expected that the next frontier for conversion to single port will be laparoscopic cholecystectomies since 100% of them are now being performed laparoscopically through multiple ports. According to the mentors at this meeting, residents without prior procedural habits learn very quickly and should be taught single port from the beginning of their training. However, only procedures that are routinely done laparoscopically should be converted to single port; those procedures that are currently performed as an open procedure should not be converted directly to single port laparoscopy.

To date, worldwide NOTES procedures number 7.000, with the U.S. accounting for about 275 of those procedures. NOTES procedures in the U.S. have had an uphill battle for both FDA clearance as well as reimbursement. Outside the U.S. patients pay for their own NOTES procedures.

Since the most popular NOTES approach is transvaginal, Curcillo pointed out that should NOTES hybrid procedures become more widely utilized, only 1/3 of the population would be a potential candidate if considering a transvaginal approach. Obviously men would be excluded, but additionally young women or women with prior pelvic surgeries would also be excluded, leaving about a 30% potential candidate pool for that method. To which, Michael Marohn, MD, Associate Professor of Surgery, Johns Hopkins Medical Center (Baltimore) quipped, “More than likely, there will never be a NOTES transvaginal prostatectomy.“

Reduced port learning process

Curcillo, who has never changed his method in more than 500 single port cases using his own single port access (SPA) technique, stressed the importance of mimicking standard multi-port laparoscopic technique with the only difference being a reduced number of holes. In order to learn single port surgery, Curcillo advocates beginning with the normal five ports and then reducing one port at a time until only one or two ports are being used routinely. The exact opposite of that approach is being advocated by Sharona Ross, MD, Assistant Professor of Surgery, University of South Florida, Tampa General Hospital (Tampa, Florida).

In her presentation that followed his, she said that she felt single port surgery will replace conventional laparoscopy for all operations that are now using conventional multi-port laparoscopic technique.

She claimed “Single port surgery is here and now and growing fast. It involves a similar skill set as conventional laparoscopy and has a short learning curve.“ Ross advocates starting with a single port and adding holes as necessary. “Do not change your current surgical approach; do not change the operation. If you are changing the way you would operate using conventional laparoscopy, then something is not going well,“ she told the audience.

Ross also advocates using enabling devices but only as necessary to complete the procedure safely and limiting additional (unnecessary) cost. “You should develop your own toolbox with instruments that make it easier to address the challenge of single port surgery,“ Ross explained. (See Table 3)

Table 3

Enabling Devices for Single Port Surgery

• Articulated instruments

• Multi-trocar port

• Bent or curved instruments

• Needleoscopic instruments

• Internal retractors

• Magnetic retractors

Source: Curcillo, Ross, Industry contacts

Cost considerations

Since the inception of single port surgery, there has been a proliferation of devices to assist in performing single port procedures; however, simultaneously there has been increasing cost pressures placed on surgeons so that the current mantra is to use only additional cost instruments that are necessary to insure the safety of the patient. One audience member calculated that if a hospital performed 600 cholecystectomies a year and only used one additional multi-trocar port per procedure at an average cost of $325 each, the incremental cost to the hospital would be close to $200,000. One of the first categories of enabling devices designed for single port surgery was a single port device that accommodated multiple trocars.(See Table 4)

Table 4

Single Port, Multiple Trocar Devices

Brand name

Manufacturer

Air Seal

Surgiquest (Orange, CT)

Gelport

Applied Medical

(Rancho Margarita, CA)

SILS port

Covidien (Norwalk, CT)

Single incision, multiple low profile trocars

(Curcillo technique)

SSL Access System

Ethicon Endosurgery

(Cincinnati)

Triport

Olympus

(Center Valley, PA)

Quadport

Olympus

(Center Valley, PA)

Uni-X

Pnaval Systems

(Morgansville, NJ)

Source: William E. Kelley, Jr., MD

Regardless of whether surgeons are using the reduce-one-port-at-a-time learning process advocated by Curcillo, or the start-with-one-port-and-add-as-needed learning process supported by Ross, those medical device manufacturers that have developed single port instrumentation will probably need to adjust their sales forecast downward as cost pressures are exerted and surgeon skills are increased that allow surgeons to depend more on their skills and less on enabling devices.(See Table 5)

Table 5

Cost Considerations for Robotic &

Single Port Surgery

Additional costs

No additional costs

Surgeon spends more

operating time

Payer pays the same

Hospital uses more OR time

No difference for patient

Hospital pays for extra device cost

Since the insurance companies pay the same per procedure whether it is multi-port, single port, or robotic; the surgeons and the hospitals are absorbing the additional costs. For cholecsystectomies, Curcillo's SPA technique that does not entail any special instrumentation actually costs the hospital $190 less than multiport because they are using fewer (single vs. multi) instruments, demonstrating that single port can be performed without incremental cost.

Need for standardization of new techniques

William Kelley, Jr., MD, Richmond Surgical Associates (Richmond, Virginia), Director of the Master's course on Reduced Port Surgery, addressed the safety, cost, and safe adoption of single port surgery and noted that at the present time there is very little standardization in any aspect of single incision surgery, including nomenclature. (See Table 6)

Table 6

Nomenclature being used to describe

Single Port Surgery

LESS

Laparo-Endoscopic Single-site Surgery

NOTUS

Natural Orifice Transumbilical Surgery

OPUS

One Port Umbilical Surgery

SILS

Single Incision Laparoscopic Surgery

(Covidien)

SIMPL

Single Instrument Port Laparoscopic Surgery

SLAPP

Single Laparoscopic Port Procedure

SLIT

Single Laparoscopic Incision Transabdominal

SPA

Single Port Access (Curcillo)

SPLN

Single Port Laparoscopic Surgery

SSL

Single Site Laparoscopy (Ethicon Endosurgery)

TTLS

Totally Transumbilical Laparoscopic Surgery

TUES

Transumbilical Endoscopic Surgery

Source: William E. Kelley, Jr., MD

With standardization for all current procedures becoming a fait de compli; Kelley, along with many of the surgeons presenting in the master's course, emphasized the need especially for standardization of single port technique and referred to a committee meeting on this topic during the upcoming American College of Surgeons (Chicago) annual meeting in October.

Robotic surgery of the future

In a private interview with BB&T, Ross opined that in the future all operations would either be performed using single port laparoscopy or the robot. There are 10 million surgical procedures performed annually in the U.S. and 3 to 4 million of those are performed via minimally invasive surgery. Ross believes that there will be an evolution into two camps: robotic or single port. Current conventional multiport laparoscopic procedures will no longer exist, nor will open surgery. In essence, she feels that procedures that are performed frequently, do not require a high degree of special skill, and do not warrant the high cost of using the robot, will all be performed using single port surgery. Other procedures that are complex, rarely performed, often involved with cancer resection, frequently require reconstruction or anastomosis, require a high skill level and were previously performed as an open procedure will be performed robotically. (See Table 7)

Table 7

How Procedures will be Performed in the Year 2020

Single Port Procedures

Robotic Procedures

Bread & butter operations

Complex procedures

High volume

(frequently performed)

Infrequently performed

Reconstructive procedures

Low cost (robot not justified)

High cost justified

Requires high level of skill

Previously performed open

Easy skill level

Often cancer resection

Source: Sharona Ross, MD, Assistant Professor of Surgery, University of South Florida

Currently the da Vinci robot – the only one on the market – manufactured by Intuitive Surgical (Sunnyvale, California) is not FDA cleared, nor is capable of, single port surgery although a single port system is in development.

However, it is estimated that 85% of all conventional multiport laparoscopic prostatectomies performed in the U.S. in 2011 will be done on the robot. Driven by patient demand and not surgical necessity, there are currently 2250 robots placed worldwide at an average price of approximately $2 million each, with gynecology motivating the current expansion. While many experienced surgeons have said that the robot is a crutch for poor surgeons, it appears that by training new surgeons on the robot, there may be no need for good surgeons who can perform difficult procedures without the robot in the future. In fact, several of the leaders at this meeting have commented on the poor surgical technique of incoming residents since they have had little surgical training other than laparoscopic. Overheard at this conference was “New residents could not possibly convert to an open surgery if a problem arose. They could, however, convert from a single port to a multi-port procedure.“ Surgeons who have embraced the robot may have realized their own planned obsolescence.

Potential to eliminate general anesthesia for select cases

Ross also discussed the highly controversial issue of being able to perform some single port surgeries without general anesthesia. Her first case without general anesthesia was on a surgeon who was deathly afraid of general anesthesia and requested that Ross try using an epidural, the same as is used for Caesarian sections, instead of general anesthesia. Ross and her assisting anesthetist were able to paralyze the patient almost up to her diaphragm but still keep her breathing on her own. With careful synchronization of suturing with the patient's breathing, the procedure went well and now Ross offers this to select patients routinely. The cost savings as well as patient benefits are significant. (See Table 8)

Table 8

Cost Savings & Patient Benefit When Eliminating General Anesthesia

Patient Benefits

• No nausea

• No grogginess

• Nominal recovery room time if any

• Go home significantly quicker

• No sore throat from intubation

• Less meds used

Cost Savings

• Significantly shorter OR time

• Epidural is done prior to going to OR

• No intubation

• No induction of anesthesia

• Nominal costly recovery room time

Source: Sharona Ross, MD, Assistant Professor of Surgery, University of South Florida

Tissue ablation therapies

Professor Doron Kopelman, MD, Department of Surgery, HaEmek Medical Center (Haifa, Israel) moderated a general session on 'Directed Energy for Tissue Ablative Therapy' that included presentations on radio frequency (RFA), interstitial laser, plasma and non-invasive high intensity focused ultrasound (HIFU). Kopelman opened the session by saying, “We live in an era of technological revolution. The rate of change is constantly increasing and surgery is no exception. We are not far from declaring “Open Surgery“ as a sub-specialty mostly practiced in trauma and acute abdominal emergencies. Tissue ablation holds a very significant part in the revolution of minimally invasiveness. Not only are we replacing open surgical procedures, but many times replacing the entire need for surgery. We are now performing ablation as an ambulatory procedure, many times under local anesthesia or as a totally non-invasive procedure.“

In addition, he noted that ablative therapies would have a profound effect on palliative therapy where many cases of brain, liver, kidney and lung cancers will be transformed from a malignant metastatic disease to a chronic illness. (See Table 9)

Table 9

Directed Energy Modalities for Tissue Ablation

Energy source

Select Manufacturers

Radio frequency

Angiodynamics

Cryo therapy

CryoMedix

Galil

Ice Cure

HIFU

Microwave

InSightec

Irreversible electroporation

Angiodynamics

Source: Industry contacts

The use of plasma energy for tissue ablation was discussed by Farr Nezhat, MD, Professor of OB/Gyn, St. Luke's-Roosevelt Hospital (New York). Nezhat described plasma energy as the 4th stage of matter after solid, liquid and gas that we are all familiar with. Plasma surgery provides an electrically neutral energy source that does not require grounding pads; and that it cuts, ablates, and coagulates many types of tissue from adhesions to bone with very minimal collateral damage. The downside for plasma energy is that it cannot seal large vessels nor can it be delivered via a flexible instrument. Plasma Surgical (Roswell, Georgia), an exhibitor here, is currently the only vendor for this type of surgical energy source. Nezhat presented his study of 45 patients with endometriosis on whom he performed plasma surgery and demonstrated effectiveness of removing the tissue without any complications.

Kambiz Dowlat, MD, Rush University Medical Center (Chicago) presented his study on the long-term survival of breast cancer patients whose tumors had been treated with interstitial laser ablation. He percutaneously treated 64 breast cancer patients using the interstitial laser manufactured by Novian Health Systems (Chicago) that utilizes a temperature probe placed parallel alongside the treatment probe in order to determine that the laser probe has reached -60 degrees Celsius, the temperature required for 100% kill accuracy.

The first 54 patients also had a lumpectomy and their tumors were sectioned for pathology while the remaining 11 patients were only monitored for 10 years. At one year out, the tumors were no longer visible upon imaging. At 10 years out, there was a 96% total ablation of the tumor with no residual scar. Dowlat concluded, “Ten year follow up shows that laser ablation is a viable alternative to surgery for selected breast cancer patients. These patients can be monitored using MRI to detect any recurrence.“

Insightec (Carmel, Israel), along with an investment from GE Healthcare (Chalfont, UK), has developed a non-invasive system using HIFU guided under MRI that was FDA cleared in 2004 for treatment of symptomatic uterine fibroids. They have also received the CE mark for pain palliation of bone metastases in June 2007 and for adenomyosis in June 2010.

Kopelman explained how he uses MRI to identify the target lesion then directs the focused ultrasound to heat and destroy the targeted tissue non-invasively. The InSightec system has been used to treat adenomyosis, benign and malignant breast cancer, liver and prostate tumors. Research is ongoing to use the system for low risk prostate cancer, bone cancer, and recent investigations are looking into neurological tremors, strokes and possibly even bariatric treatments on the hypothalamus. For bone cancer, they have discovered that by zapping the bone mets there is a denervation of nerves resulting in pain palliation.

The drawback to ablation has been a slightly higher local recurrence rate at the site of the ablation and the fact that the tumor should be less than 4 cm (no advanced disease). However, unlike select other therapies and sometimes surgery, re-treatment is always an option with ablations. (See Table 10)

Table 10

Advantages of Ablation Therapies in General

• No toxicity

• OK to repeat treatments

• Can often be performed percutaneously

• Significantly less costly than surgery

• Can be performed laparoscopically

• Fewer complications

• Follow-ups can be monitored using imaging

• Studies comparing cryo, RF and surgery have shown comparable outcomes

Source: SLS seminars, Industry contacts

One study presented here by Jeffrey Cadeddu, MD, Professor of Urology, University of Texas Southwestern Medical Center (Dallas), compared treatment of kidney tumors using RFA energy vs. surgery. The study demonstrated that in stage 1 tumors less than 4 cm there was a 99% cancer specific survival rate and at 5 years a 95% metastasis-free rate in kidney cancer. Cadeddu noted, “The chance of developing chronic kidney disease with surgical partial nephrectomy is relatively high but lower with RFA. If looking to preserve kidney function, RFA should be considered as primary option not a secondary one. “

Kopelman presented an innovative use of HIFU that can attain transcranial HIFU ablation. He opened by stating, “For decades, therapeutic transcranial ultrasound was assumed impossible, due to disruption of the focused acoustic beam by the skull, and the production of damaging heat by the ultrasound. Novel technology using high-power phased array transducers and multiple channel driving electronics enabled a sharp focal point in the planned target. MR images provide intraoperative anatomical data to identify the target, and real-time thermo-sensitive images allow intraoperative feedback to evaluate treatment outcome and guide the therapy.“

Potential applications for transcranial HIFU technology are essential tremor, neurogenic pain, epilepsy, and Parkinson's. Researchers at the University of Virginia (Charlottesville) are targeting the hypothalamus with either ablation or stimulation to cause reduced food intake for prevention of obesity. It could also be used to disrupt the blood brain barrier for enhanced delivery of therapeutic drugs, and for lysis of blood clots to treat ischemic and hemorrhagic stroke. Preclinical studies in a variety of experimental models have shown that it is safe, feasible, reproducible, and efficacious.

Although RFA, laser, and HIFU studies were presented in this plenary session, there are two other ablative energy modalities that are also being used to ablate tumors: cryoablation and Irreversible Electroporation (IRE). Cryoablation is the use of freezing temperature, below -40°C required to cause cell death in tumors of the kidney, liver, lung, soft tissue and the prostate. Long needles or probes are inserted percutaneously into the tumor and the ice formation is monitored under ultrasound, CT or MRI, potentially resulting in less damage to healthy tissue than heat ablation. While current cryoablation requires the use of large tanks of gas, a new approach to cryoablation has been developed by CryoMedix (San Diego) that eliminates the need for tanks and reduces the length of the procedure.

Another form of ablation not represented here is irreversible electroporation provided by AngioDynamics (Queensbury, New York). IRE has European CE mark to treat kidney and lung tumors and is being studied to treat pancreatic cancer, a disease with few and morbid options.

Pancreatic cancer is the fourth leading cause of cancer death in the U.S. and advanced disease at diagnosis correlates directly with worse overall survival. Symptoms often do not present until the tumor is inoperable at which point treatment options are limited, have extreme side effects, and often only extend life by a few months. IRE has been used to treat pancreatic cancer in 4 centers in the U.S. and some have patients surviving over 2 years when the average with standard treatment is 9-12 months. There have been more than 30 cases of IRE used to treat unresectable pancreatic tumors to date in the U.S. These have been done off protocol (off-label) in major centers located in Louisville, Stony Brook, Detroit, and recently in Tampa. All cases except one have been done open using a combination of surgical resection and IRE. Results are very preliminary; however, sudden adverse events have not been a major issue and several patients are survivors at 1.5-2.5 years. There is currently an approved protocol ongoing in Europe and discussions with FDA to initiate an approved clinical protocol in the U.S.

If this conference reflects the future of surgery, then we are all in for some truly momentous changes.

No Comments