Laparoscopic Hysterectomy and Health Care in America

Introduction

The growth of managed care and the influence of third party payers in the medical decision making process have served to diminish the ability of physicians to direct the care of patients; physicians, however, still continue to be held accountable for the management of care. In the case of gynecologists performing hysterectomy, this care extends well beyond the actual operation with the global costs related to recovery and time off from work. The physician's ultimate goal is the best possible operation for each patient with minimal intraoperative and postoperative complications. As a result, even though the physician now has diminished control, he has responsibility and increased pressure to reduce global costs.

In America, hysterectomy is one of the most frequently performed operations and has a long, controversial history. The true impact on the advent of laparoscopic hysterectomy is not yet clear in America. As the millennium approaches, we are entering an interesting period in healthcare, and physicians are now with trying to contain health care costs associated with hysterectomy, and with providing quality health care to patients while minimizing costs and enhancing recovery. In certain situations, laparoscopic hysterectomies may fulfill all these goals.

Why The Recent Explosion in Laparoscopy?

With the first one being done in humans in the first decade of the 20th century in Germany, laparoscopy is not new a procedure. It was not until after the Second World War that laparoscopy became popular, when it was widely used in France for laparoscopic sterilization. The first book on laparoscopy published in English was only in 1967 by Patrick Steptoe,¹² who later became famous for having the first successful in-vitro fertilization pregnancy. Furthermore, the first American book on laparoscopy was not published until 1970 by Melvin Cohen of Michael Reese Hospital in Chicago.¹³

In the 1980s, however, several events rapidly propelled laparoscopy forward.

1.TELEVISION CAME TO SURGERY. The television industry developed cameras that became suitable for laparoscopy. Miniaturization through the use of a silicon chip was combined with greater light sensitivity. These developments led to the adoption of television in surgery, first as an operative recording device and then as a monitor for both the surgeon and the assistant to view while operating. The magnification made possible by bringing the laparoscope lens close up to the surgical field compensated for the loss of detail in the electronic image. By multiplying the eyes and hands involved in laparoscopy, "videoendoscopy" made possible more complex and extensive surgery through the laparoscope. Furthermore, more importantly, videotaping allowed physicians to share their techniques with other M.D.s and finally to the public.

2. LASER SURGERY ARRIVES!! Laser surgery increased the new enthusiasm for laparoscopic surgery, allowing safe dissection in close areas in the abdomen. Manufacturers promoted its use both to patients and physicians and added glamor to the word laparoscopy by prefixing it with LASER!! Suddenly, the public thought laparoscopy was high tech. To be or to have a laser surgeon became a status symbol to both physicians and patients. Eventually, however, surgeons realized that lasers were just another tool to be used wisely and safely but were not the "holy grail" of surgery.

3. NEW TOOLS ARRIVE!! Manufacturers expanded the availability of laparoscopic hemostatic clips, stapling devices, and suturing equipment. Reich showed that hemostasis was practical by occluding and desiccating (now termed coaptating) large vessels with bipolar electrosurgery.¹⁴ All these new tools have made possible extirpative surgery on structures such as ovaries, uteri, appendix, kidneys, and gallbladders.

The General Surgery "Discovery" of Laparoscopy

In the summer of 1987 in Lyons, France, a watershed event occurred in laparoscopy when Phillipe Mouret and colleagues successfully performed the first laparoscopic cholecystectomy, an event that revolutionized general surgery.¹⁵ In the United States, Eddie Joe Reddick and Douglas Olsen worked to refine "lap chole" and to develop cholangiography. These two general surgeons developed and first offered laser laparoscopic cholecystectomy with cholangiography and developed the first "hands-on" animal training courses in our animal lab at Centennial Medical Center here in Nashville. We co-authored the first report on "lap chole" in English in 1989.¹⁶ Our videotapes shown at USA national surgical meetings at that time led to the explosion in the USA of extensive publicity over "lap-chole." As they say, "the rest is history." Surgeons then rushed to learn laparoscopy supported by laparoscopic instrument manufacturers such as U.S. Surgical's Autosuture or Johnson & Johnson's Ethicon EndoSurgery. Thus began the multibillion dollar disposable laparoscopic instrument industry.

Not to be outdone by their aggressive general surgeon friends who so rapidly embraced "new" laparoscopy, gynecologists who had much more experience over years of performing basic laparoscopy followed their competitive instincts and used the improved laparoscopic equipment to perform more extensive gynecologic laparoscopic procedures, e.g. the various types of laparoscopic hysterectomies available today in most American operating rooms.

History of Hysterectomy

Hysterectomies have a long history, with the first vaginal hysterectomy reported in 1813, and the first elective abdominal hysterectomies in 1863.¹ These two operations were constantly refined over the remainder of the 19th century and by the mid portion of the 20th century, had become established as the classic techniques. Since the middle of this century, however, there were no substantial changes in the classic techniques of either abdominal or vaginal hysterectomy until 1989, when the first reported laparoscopic hysterectomy was reported.²

Each gynecologist believes that he or she is aware of the correct indications for performing each type of hysterectomy, and when each should be performed. The actual percentages of abdominal or vaginal hysterectomies vary from country to country and from region to region of the United States. A few expert vaginal surgeons are capable of removing the majority of uteruses by vaginal hysterectomy. Kovac⁴ reported that in a series of 617 patients he was able to perform vaginal hysterectomy in 89%. However, in contrast to these individual reports, a national survey of every hysterectomy performed in Finland in 1995 indicated that 93% of cases were performed by the abdominal route.⁴

The varying proportions of abdominal and vaginal hysterectomies reported indicates that after more than one hundred years of experience with the most commonly performed major surgical operation in the world (hysterectomy), the gynecological profession as a whole has no clear indication of the optimum method by which to perform a hysterectomy in differing situations! The choice of method of the operation depends more upon experience and personal bias of the surgeon than upon a critical evaluation of the operative and outcome data.

Now, with ten years of experience with laparoscopic hysterectomy, a third variable has been introduced. Alan Johns, in a review on the medical and economic impact of laparoscopic hysterectomy in Fort Worth, Texas, stated "the route of hysterectomy is usually determined by the skill, experience, and preferences of the operating gynecologist. Few other parameters matter."⁵Applying Science to Hysterectomy

Another important development in the history of intelligent medical care is the concept of evidence-based medicine. Various authors point out that all clinical data does not appear to be of equal importance when assessing the worth of a technique. Individual case series are of least value, non- randomized controlled trials and case controlled studies are of somewhat greater value, and randomized controlled trials (RCT) are of even more value. Perhaps of greatest value, however, is the meta analysis of a number of good RCTs. Many scientific and funding bodies are now insisting that evidence be categorized according to the quality.

In the real world, the problem with evidence based medicine is that even though you have evidence which is based on scientific data, it is difficult to convince practitioners that this evidence should lead to changes in daily practice. Changes can cause physicians considerable discomfort and inconvenience. To be effective as surgeons, it is essential that physicians believe that whatever operation they recommend to their patients is the best available. If they doubt the superiority of their selection and their techniques, then physicians may be compromising their patient care.

Which Is The Best Type of Hysterectomy?

It is accepted that abdominal hysterectomy can be used for every indication and can be considered to be the "default" operation. That is, when a procedure cannot be carried out vaginally or via laparoscopy, it can always be done by the abdominal route: "If we have trouble with a laparoscopy, we can always open you up." Amazingly, the two approaches to the most common major operation in the world had never been subjected to a single formal prospective randomized trial until the recent introduction of laparoscopic hysterectomy. In the past, most studies were retrospective studies, and those before 1970 generally found vaginal hysterectomy to be associated with more morbidity than abdominal hysterectomy, particularly fever and infections in the vagina.

Facts Concerning Complications of Abdominal and Vaginal Hysterectomy

• There is a higher incidence of bleeding complications after vaginal hysterectomy.
• Overall blood transfusion rate has fallen in the last eighteen years, but is still higher with abdominal hysterectomy.
• Abdominal hysterectomy probably still has a higher rate of unexplained infection than vaginal, but the rate of urinary tract infection seems to be similar for both groups.
• There is a greater risk of bladder injury after a vaginal hysterectomy, and the more difficult the procedure, the higher the incidence of bladder injury with vaginal surgery.
• Injuries to the ureter appear to be more common after abdominal hysterectomy. These conclusions are based on our review of sixty-five series of complications reported after abdominal or vaginal hysterectomy since the CREST study was published in 1982.⁶

The lack of relevant data concerning abdominal and vaginal hysterectomy makes it difficult to compare data in the first decade for laparoscopic hysterectomy. Since physicians are just finishing the first decade of laparoscopic hysterectomy, gynecologists are still modifying their techniques and are still early in their learning curve. Thus the number of complications in some of the initial series has been higher than it will be in the future as clinicians gain further experience and develop a more skilled operative team and define more reliable and safer operative techniques.

What About The Safety and Efficacy of Laparoscopic Hysterectomy?

There have now been at least six randomized controlled studies comparing laparoscopic and abdominal hysterectomy. These all show quicker recovery, less complications, and less patient discomfort with the laparoscopic approach. At the same time, there have been two small randomized controlled trials comparing vaginal hysterectomy to laparoscopic hysterectomy. Both show similar pain with reduced costs from vaginal hysterectomy. This would clearly be expected, since there is minimal equipment required for vaginal hysterectomy when compared to that required for laparoscopic hysterectomy.

Our conclusion from a careful review of the literature is that after the first decade of laparoscopic hysterectomy, clearly there is more rapid recovery, with no greater risk of complications in the hands of physicians who have experience with laparoscopic hysterectomy of various types. Postoperative pain is less severe compared to abdominal hysterectomy and recovery is clearly more rapid than with either vaginal or abdominal procedures.

Laparoscopic Hysterectomy - The First Decade

Clearly, as more physicians have become comfortable doing laparoscopic hysterectomies, it has increased the numbers of vaginal hysterectomies which they perform without laparoscopy. This has reduced the overall numbers of abdominal hysterectomies being performed. The reasons for this are clear if one is active in surgery. As a physician begins to do laparoscopic hysterectomy, he gains more confidence and skill at vaginal surgery. There is nothing like having a laparoscope in the abdomen looking from above while trying to do difficult vaginal surgery. This enhances visibility, improves safety, and encourages the surgeon to be more aggressive.

Initially, the concerns of the critics of laparoscopic hysterectomy were that laparoscopic hysterectomy would be used to replace vaginal hysterectomy. This was never the thought, as the initial article by Reich stated that careful investigation of laparoscopic hysterectomy should be undertaken to possibly replace some abdominal hysterectomies. It was never the intent of any of the early physicians doing laparoscopic hysterectomies to "compete" with vaginal hysterectomies. Clearly, from the patient's standpoint, if a vaginal hysterectomy is indicated and if the gynecologist feels comfortable with that approach, then this should be the treatment of choice, as it is most cost effective, and is a tried and true procedure. However, the outcome is based on the skills of the surgeon as well as the pathology involved and the condition of the patient.

Various Types of Laparoscopic Hysterectomy - Confusing Terms to Us All

The generic term laparoscopic hysterectomy covers several types of procedures. It can be confusing sometimes because the terminology has not yet been well defined or standardized. The first term used was LAVH, which stands for Laparoscopically Assisted Vaginal Hysterectomy. Surgery begins by laparoscopy, and then is completed vaginally, with the uterus being removed through the vagina, but with laparoscopic observation from above. Total laparoscopic hysterectomy involves doing the entire procedure through the laparoscope. Subtotal or laparoscopic supracervical hysterectomy (LSH) is similar to open subtotal hysterectomy done earlier in this century, in which the uterus is amputated between the cervix and the fundus. In this case, the vagina is not opened, and the entire body of the uterus, tubes, and ovaries, if indicated, are removed by laparoscopy through small abdominal incisions. The first laparoscopic subtotal hysterectomy was reported in Germany in 1991.⁷ Since that time, several large series have been reported, including 500 cases from Belgium with no complications and very rapid recovery.^8,9

Table 1- Laparoscopic Hysterectomy Various Terms

The concept of leaving the cervix is somewhat controversial, particularly among older gynecologists in America, who have been trained to "always remove the cervix." Many physicians do not feel comfortable with laparoscopic supracervical hysterectomy because of biases from their previous training. On the other hand, many women seek out this procedure because it potentially gives better postoperative sexual function while minimizing the complications and costs associated with laparoscopic hysterectomy.

In our experience,

¹⁰

we have found operating time (time is money in the operating room) to be much shorter with laparoscopic subtotal hysterectomy compared to total laparoscopic hysterectomy. Our patients have been very happy with the procedure and we have been able to reduce our global operating costs significantly compared to 1992 costs with LAVH.

¹¹

The bottom line global health care costs associated with LSH are less than with other forms of laparoscopic hysterectomy. Since the patient can return to work or full activities much sooner, this reduces costs to the employer and society. The average time to return to work for our patients who have undergone subtotal laparoscopic hysterectomy is three weeks, compared to four weeks for those undergoing laparoscopic assisted vaginal hysterectomy, six weeks for vaginal hysterectomy, and approximately eight weeks for total abdominal hysterectomy.

So Why Should Hospitals Embrace Laparoscopic Hysterectomy?

• Global costs are reduced, thus benefitting all parties
• Hospitals Maximize use of high income areas of hospital, e.g. surgery, recovery room, short stay facility
• Enhances reputation of the hospital as a "Center of Excellence"
• Attracts desirable payer mix with high pay insurance plans (working patients who want rapid recovery to return to work)
• With proper cost containment efforts can still be profitable in capitated systems

Why Most Hospitals Currently Don't Promote Laparoscopic Hysterectomy

• Because they lose money on the procedure!!!
• Poorly motivated or trained GYN staff = high costs and complication rates with prolonged operating times
• Excess waste of intraoperative equipment by using disposable equipment unnecessarily
• Early data that suggested procedure costs exceed payor reimbursements
• Ignorance, inertia or disinterest of surgical and administrative staff
• Inadequate O.R. equipment and support = long operating times, higher complication rates, frustrated surgeons, excessive turn-over time between cases

What is the Secret to Profiting with LAVH Today?

There is a clear need for hospitals to offer hysterectomy in a cost effective manner to survive in today's healthcare environment.

How Can A Hospital Profit From An Active Hysterectomy Program in Today's Health Care Environment?

• Recruit or educate and train GYN staff MDs to become "expert" surgeons - "Best of the Best" doctors have best outcomes
• Provide MDs with cost profiles of hysterectomy to enhance MD's incentive to reduce costs - No doctor wants to be the high cost provider
• Promote vaginal hysterectomy or laparoscopic hysterectomy over total abdominal hysterectomy
• Educational programs
• Inservice to staff to support excellent efficient operations
• Patient educational promotion
• Provide incentive to MDs with extra payment for LH or Vag Hyst over TAH
• Provide excellent reusable cost effective equipment and encourage MDs to use them
•  

By merely going back to safe effective use of reusable laparoscopic tools, a hysterectomy program can become profitable.

A recent widely read 1997 editorial in the prestigious journal Fertility and Sterility addressed this issue with a catchy title - "There's a Hole in My Bucket: The cost of Disposable Instruments."¹⁷ The authors concluded the following:

• Bowel injuries with disposable trocars appear to be three times more common (complications = cost)
• There is no evidence reusable laparoscopic instruments increase infections
• Savings per case is significant with reusables

Several peer review articles have now reported significant cost savings with laparoscopy by use of reusable instrumentation. Here are some quotes.

• "When actual costs have been analyzed, it appears that the cost per case of disposable instruments is approximately seven times that of the reusable version." ¹⁸
• "The cost of the disposable cannula per use was higher than that of the nondisposable cannula, $63.71 and $1.35, respectively, and thus increased hospital costs for laparoscopic procedures. Furthermore, although the charge to patients reflects a significant mark-up from the hospital costs for disposable cannulas, capitation agreements eliminate any possibility of a real hospital profit with the use of these cannulas." ¹⁹
• "The routine use of disposable equipment and automatic disposable staplers for laparoscopic hysterectomies is very debatable as the considerable increase in cost is not accompanied by any benefit for patients or society." ²⁰
• "At current costs to our hospital, over $2,000 is saved per operation with our conversion to reusable instrumentation where possible. This has occurred with reduced operating times and no increase in complications." ²¹

What Is The Quickest, Easiest Way To Implement An Effectuve Laparoscopic Hysterectomy Reusable Instrument Program?OUTSOURCE THE PROBLEM. We practice at Columbia Centennial Medical Center (CMC), the "home office" facility in Nashville for America's largest hospital chain. In spite of years of expertise in all types of laparoscopic operations, CMC recently contracted with an innovative local company, American Endoscopy Services (AES), with the experience to solve this problem. The information in the box below is taken directly from AES promotional information provided to our hospital O.R. staff, and clearly defines the problem and their solution. Since we have implemented this simple outsourcing solution, we have rapid turnover time between cases and a high number of our laparoscopists are switching to reusable equipment with no problems or complaints.

This is now a win-win situation for all of us at CMC. Our hospital profits; we doctors have safe, clean tools; and patients receive the clear benefits of minimally invasive surgery with low risk of complications.

American Endoscopy Services (AES) - Nashville, Tennessee (Direct quotes from company literature)

"In today's rapidly changing healthcare environment, hospitals face extraordinary pressure to reduce operating expenses and improve patient care. AES offers a unique solution through our comprehensive surgical support program. In addition to reducing laparoscopic procedure costs by an average of 30%, our technical support improves patient care at no capital expense to the hospital."

"The AES program offers two principle services for one per-procedure charge:""1. We provide all new state-of-the art reusable instrumentation and video equipment for rigid-scope endoscopy surgery. The products we provide are based on the preferences of your staff and surgeons. AES works with your staff and surgeons personally to educate them on the safety and cost-reducing benefits of the most modern reusable instruments for rigid-scope endoscopy. AES is responsible for all instrument care, cleaning, and maintenance."

"2. We provide highly trained AES surgical technicians on site to assist your staff in every laparoscopic, thoracoscopic, and hysteroscopic procedure. Our technicians assist with preoperative room set up, intraoperative technical assistance, and postoperative room turnover."How Laparoscopic Hysterectomy Can Help Reduce Employer Health Care Costs
by Jim Astuto - Regional Healthcare Manager, GTE Corporation

Many employers don't understand the total overall economic benefits that can be realized when laparoscopic hysterectomy (LH) is performed instead of total abdominal hysterectomy (TAH). However, GTE Corporation, the telecommunications giant, is not one of them because GTE's healthcare cost management strategy is focused on the quality of care rather than strictly the cost of care. GTE realizes that the best care is always the least costly, especially when it is delivered by high quality cost effective providers.

Laparoscopic hysterectomy is a perfect example of how the best care can help reduce an employee's total overall healthcare cost. While the sum of physician and hospital fees for laparoscopic hysterectomy can sometimes be more than that of total abdominal hysterectomy, GTE beneficiaries having an LH are able to return to normal activities much sooner than those who have a TAH. This allows them to return to work earlier thus reducing disability, replacement worker and lost productivity costs for GTE. These cost savings will more than offset the occasionally high additional direct medical costs of laparoscopic hysterectomy in GTE's view.

So what has stopped LH from becoming the standard of care? One of the main problems is that health plans don't require it instead of TAH because they are only concerned about the direct medical cost associated with a hysterectomy and are not accountable for the total costs of the procedure to the employer. As long as they continue to be measured only on direct medical costs ( and LH cost more than TAH), it will not be in their financial interest to encourage network providers to perform LH instead of TAH. While the health plans don't have a financial interest in the cost of disability, productivity or the other non-medical costs associated with hysterectomy, employers like GTE do and they want global costs to be as low as possible. Thus, if LH is going to be a tool that helps better manage the total costs associated with hysterectomy, employers must demand it from their health plans and healthcare providers. We want the best care by the best doctors for our employees and feel cost effective LH performed by "expert" experienced gynecologic surgeons clearly is better for the GTE patient when a hysterectomy is necessary.

The reporting of LH under the frequency of procedures section in the 1998 HEDIS data that will be reported by health plans in 1999 will be one of the first steps to measure the actual utilization of LH in managed care plans. With this information available for the first time, interested employers like GTE will be able to demand improvement from health plans providers in this area. - James Astuto, Regional Healthcare Manager, GTE

Conclusions

Hysterectomy will always be necessary.It is time that we all focus on the real reason to be in the health care business - to deliver quality care to sick patients with minimal risk or discomfort and quick recovery in the most cost effective manner possible. We conclude that appropriately performed laparoscopic hysterectomy is a cost effective operation that meets all our common goals for the women of America. Major abdominal surgery can be avoided. Women recover quicker with less pain. Payors (such as GTE) benefit with cost savings and healthier employees; insurance companies save money, and finally, hospitals which are well run can survive and profit as well. Thus have we created a win-win situation.

Remember the "Right Stuff" movie. The "right" patient with the "right" doctor, in the "right" operating room and with the "right" tools = successful avoidance of abdominal hysterectomy.

References:

References

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