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UPDATE TECHNOLOGY NEW DEVELOPMENTS THAT ARE CHANGING PATIENT CARE

HYSTEROSCOPIC STERILIZATION New devices do not require abdominal access or general anesthesia, and offer rapid recovery

ith over 50,000 completed hys- Adiana (not yet available in the United teroscopic sterilization proce- States) uses a combination of controlled Barbara S. Levy, MD W dures worldwide, and 5 years of epithelial destruction and insertion of a Medical Director, Women’s Health data, what do we know so far about this porous biomatrix to induce vascularized Center, Franciscan Health System, innovation? It is now almost 4 years since tissue ingrowth. A catheter placed through Federal Way, Wash Dr. Levy is a member of the the FDA approved Essure (Conceptus; San the operating channel of a small hystero- OBG MANAGEMENT Board of Editors Carlos, Calif), the ®first hysteroscopic steril- scope delivers low-power bipolar electro- and serves on ACOG’s Coding and Dowden Health Media Nomenclature Committee. She is also ization method available for use in the surgical energy to the tubal orifice (average ACOG’s representative to the AMA’s United States. Two other systems are in the less than 1 watt to the endosalpinx). A RBRVS (resource-based relative value works:Copyright Adiana (Adiana; Redwood City, pushrod then delivers a small porous system) Update Committee. For personal use only Calif) has completed its Phase III clinical matrix of material into the tubal lumen. trial and Ovion (American Medical Ingrowth of healthy, vascularized tissue Systems; Minnetonka, Minn) is just begin- occurs over approximately 3 months, to IN THIS ARTICLE ning its clinical trial this year. occlude the tubes. Retention of the matrix and tubal ❙ Tricks for easier occlusion are documented by both trans- bilateral placement vaginal ultrasonography and hysterosalpin- ❚ Comparison of the devices Page 29 gogram before patients may discontinue Essure is a disposable delivery system with additional contraception. ❙ What to tell patients polyethylene (PET) fibers wound in and around a stainless steel inner coil. An outer Page 32 coil of nitinol, a superelastic titanium/nickel alloy, is deployed to anchor the device ❚ Accessing the tubes across the uterotubal junction. Wound One of the greatest hurdles for occluding down, the micro-insert is 0.8 mm in diam- the fallopian tubes hysteroscopically is eter. Once released, the coil expands to 1.5 access to the tubes. Both the Adiana clini- to 2.0 mm to hold the inner coil and PET cal trial (not yet published) and the post- fibers in place at the uterine cornua. market analysis of Essure (not yet pub- Over a period of about 3 months, the lished) have demonstrated excellent bilat- PET fibers elicit tissue ingrowth and prox- eral placement rates. imal tubal occlusion. Women must use Technique is not hard to learn. Both types of additional contraception during this time. devices are inserted through the operating Documentation of occlusion by a hysteros- channel of a small hysteroscope. Initial con- alpingogram about 3 months after device cerns about the ability to access the tubal placement is required before patients may ostia do not appear to be an issue—at least rely on the device and stop birth control. for those early-adopter physicians perform-

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UPDATE TECHNOLOGY CONTINUED

ing the procedures. Both clinical trials included gynecologists who were not expe- Tricks for easier bilateral placement rienced in operative hysteroscopy. These I have incorporated the following tips and tricks into my office studies found that cannulation of the tubes practice with great results. Patients are thrilled with their experience is a technique that is easy to learn and rap- and leave ready to recruit their friends for the procedure. idly accomplished in most circumstances. • Pretreatment with a nonsteroidal anti-inflammatory Bilateral placement rates were similar for drug to block prostaglandin release and uterotubal spasm both devices in the pivotal trials: Adiana 95% (612/655); Essure 90% (464/518). • Scheduling the procedure for the early follicular phase of the menstrual cycle to minimize shaggy endometrium, or What are the contraindications? • Suppressing the endometrium with progestins from the Approximately 10% of patients have factors first day of menses until the scheduled procedure that preclude bilateral device placement: • Use of warm fluid for uterine distension to reduce spasm Anatomic factors • Placement of topical lidocaine gel into the uterus • Blocked or stenotic tubes 10 to 15 minutes prior to the procedure • Intrauterine adhesions • Use of a pressure bag to assure adequate uterine distension • Visual field obstructed by polyps, fibroids, or shaggy endometrium • Lateral tubes Device or procedure failures due to clinical trial were excluded from this • Tubal spasm analysis. The bilateral device placement • Patient pain/intolerance rate for these women treated by novice • Device malfunction users is over 94%. Adiana’s Phase III trial A second procedure (after correcting data demonstrate a similar bilateral suc- the initial problems) will be successful in cess rate. It appears that despite the misgiv- many women who have what appears to ings of many ObGyns, these systems are be a technical glitch. easy to learn.

❚ Clinical outcomes, so far Patient safety FAST TRACK Ultimately, of course, the success of these Few complications have been reported Despite the procedures and the benefits to our patients with either technique. There were the will be determined by the placement rates in expected rare vasovagal reactions, as well misgivings the real world and the ability of a majority as 2 cases of hypervolemia with Essure of many ObGyns, of women to rely on the devices for perma- and 1 case of hyponatremia in the Adiana these systems nent sterilization. trial. Both of these situations should be are easy to learn What can we say so far? avoidable with proper monitoring and limiting distension fluids to isotonic solu- Bilateral placement rates tions. All patients recovered fully. There Although the bilateral placement rates for were no problems with persistent pain or Essure in the pivotal trial were 88% with changes in menstrual patterns at 1 year in one attempt, increasing to 92% of all the Essure trial. patients enrolled with a second attempt, the Expulsion of the devices was associated data from the postmarket study is even more with proximal positioning of the devices in promising. After FDA approval in all cases (3%). Patients had no symptoms, November 2002, the manufacturer trained and most were able to have a second proce- gynecologists in the procedure, and then dure with excellent placement and retention. monitored clinical outcomes in the initial Expulsions were identified at the postproce- cases performed by these surgeons once they dure scout film or hysterosalpingogram. had completed their training and mandatory Tubal perforation was noted in 0.9% of the proctored cases (data not yet published). patients. Predisposing factors were preex- Physicians who participated in the isting tubal occlusion or hydrosalpinx.

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Essure

Delivery. An outer coil of nitinol, a superelastic titanium/nickel Occlusion. Over about 3 months, the PET fibers elicit tissue alloy is deployed to anchor the device across the uterotubal ingrowth and proximal tubal occlusion. Women must use junction. Once released, the coil expands to 1.5 to 2.0 mm to additional contraception during this time. Documentation of hold the inner coil and PET fibers in place at the uterine cornua. occlusion by a hysterosalpingogram is required before patients may discontinue additional contraception.

CONTINUED Perforations were asymptomatic, as well. What are the potential complications? Laparoscopic evaluation in 3 cases demon- The rare but devastating complications FAST TRACK strated no adhesions or reactions to the tiny associated with laparoscopic sterilization Access to both perforation sites. should be avoidable with the hysteroscop- Anesthesia. Because hysteroscopic sterili- ic approach—at least for the 90% of tubes was feasible zation procedures may be performed with- patients for whom access to both tubes is in 90% of patients out general anesthesia and by design avoid feasible. the need to access the abdominal cavity, Ideal candidates. Hysteroscopic access they should be inherently safer for patients seems to be the ideal approach for occlu- than the other available surgical steriliza- sion of the fallopian tubes in patients tion methods. In the Essure and Adiana tri- with medical conditions that may als,1 more than 50% of the patients under- increase the risk of abdominal access, or went their procedures under local anesthe- for whom general anesthesia imposes sia with no additional intravenous seda- added risk. tion. The others had local anesthesia with Problem conditions. The following clinical IV sedation. Only 1 patient (in the Essure conditions and comorbidities all present trial) underwent general anesthesia. significant challenges for the laparoscopic Patient satisfaction and tolerance of the surgeon: procedure were excellent; 88% of patients • Cardiac disease described their experience as good to • Thrombophilias excellent. Only 4% rated their procedure • Immune suppression pain as severe. At discharge (approximate- • Renal transplant ly 40 minutes after conclusion of the pro- • Morbid obesity cedure), 79% of patients had no pain and • Previous abdominal surgery, required no pain medication. especially bowel procedures

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Adiana (not yet available in the United States)

Delivery. A catheter placed through the operating channel of a Occlusion. Ingrowth of healthy,vascularized tissue occurs over small hysteroscope delivers low-power bipolar electrosurgical approximately 3 months, to occlude the tubes. Retention of the energy to the tubal orifice. A pushrod then delivers a small matrix and tubal occlusion are documented by both transvaginal porous matrix of material into the tubal lumen. ultrasonography and hysterosalpingogram before patients may IMAGES: RICH LAROCCO discontinue additional contraception.

How many pregnancies? (6,860 woman-months of use as of There have been no pregnancies in Phase II September 2005). One resulted from an and III trials of Essure, thus far. In July error in interpreting the hysterosalpin- FAST TRACK 2003, Cooper et al1 reported no pregnan- gogram. The other did occur with a prop- Analysis of all costs cies in 7,532 woman-months of use. erly placed device and occlusion demon- Conceptus is aware of 64 pregnan- strated on hysterosalpingogram. found a significant cies among more than 50,000 proce- It appears that hysteroscopic steriliza- savings to the dures performed worldwide. None tion with Essure will have acceptable and healthcare system, appeared to have occurred with proper preventable failure rates (longer term data compared with demonstration of bilateral tubal occlu- and postmarket analysis are not yet avail- sion after device placement. Most able for the Adiana device). The calculat- laparoscopic appear to be luteal phase pregnancies ed 5-year success rate is more than 99% techniques present at the time of the sterilization for Essure; this compares favorably with procedure, or failure of either the patient all other surgical sterilization methods. or the physician to assure tubal obstruc- tion prior to stopping additional birth control methods. ❚ Do benefits There are no documented ectopic pregnancies, although 1 of the 64 reported outweigh costs? cases may have been a very early tubal ges- The overall cost of hysteroscopic steriliza- tation. The patient was treated with tion methods compares favorably with methotrexate without firm documentation laparoscopic approaches. The expense of of the location of the pregnancy. the disposable equipment is recouped by There are 2 pregnancies among the avoiding the costs of general anesthesia, 605 patients with bilateral Adiana devices and operating room and facility charges.

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Photofacials clear pigmented Advantages of the office setting and vascular lesions for Payment for physicians is slightly more than a fresher skin tone, with the reimbursement for laparoscopic steriliza- no down-time required. tion performed in a facility. The real benefit to ObGyns, however, is in mov- ing the procedure into the office environment. This allows us great flexibility in scheduling, and avoids the “down time” required for trav- eling to a facility, waiting for operating room turnover, anesthesia, and paperwork. Benefit to healthcare systems. Researchers in closed healthcare systems have analyzed the expenses associated with Essure compared with laparoscopic tubal sterilization. When all costs associated with hysteroscopic sterilization are considered, including the need for additional procedures (when the tubes are not accessible or the procedure fails) and the 3-month hysterosalpingography, there remained a significant savings to the healthcare system for these procedures, compared with laparoscopic techniques.2

❚ What to tell patients Ask women who are currently using contra- ceptive steroids about their menstrual cycles before they started hormonal birth control. Remind women who had menorrhagia or irregular cycles that no method of sterilization will manage their cycles. The addition of endometrial ablation to the hysteroscopic sterilization procedure is an option.3 However, only 1 of the global ablation technologies currently has FDA approval for concomitant treatment with Essure: Thermachoice (Ethicon Women’s Health and Urology; Somerville, NJ).

Alternatives to permanent sterilization In counseling women about permanent sterilization, it is important to cover the alternatives, as well. Leg Veins • Photofacials • Permanent Hair Reduction IUDs. We should also consider the lev- Pigmented Lesions • Rosacea • Acne • Vascular Lesions onorgestrel-containing intrauterine device (IUD), Mirena (Berlex; Montville, NJ), for patients with menorrhagia who desire long- term contraception. Studies have demonstrated excellent patient satisfaction with this system and reduction in menstrual blood loss

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equivalent to endometrial ablation.4 tion when the policy covers sterilization. Although not a permanent solution, the Determination of coverage by Medicaid IUD does provide superb contraception, has been secured in at least 36 states. failure rates are similar to sterilization, and management of menorrhagia is excellent, and the cost is less than 10% of a com- bined endometrial ablation and steriliza- ❚ Past the tipping point tion procedure. The ParaGard copper-con- It is time to begin to adopt this technology taining IUD is a good choice for women into routine gynecology practice, for the with normal or light flow, but not for those benefits it offers patients, and practicing with heavy cycles. surgeons, as well. The data are accumulat- Systemic hormone methods. For women ing on the safety and effectiveness of hys- willing to consider systemic hormones, Depo- teroscopic sterilization techniques—more Provera or the Implanon implantable rod than 50,000 procedures have been per- provide excellent long-term contraception. formed worldwide, and we have 5 years of Vasectomy. Remember that vasectomy data. remains an option; however, many women An apt analogy. Although it is true that we want the assurance that they are in control. might initiate this approach in up to 10% of women who may ultimately require laparoscopy, there appears to be little downside to the attempt. I would suggest ❚ Coding and insurance the analogy of attempting an endometri- The difference in payment for hystero- al biopsy in the office in lieu of a D&C scopic sterilization can be considerable, under anesthesia for postmenopausal depending on the site. When performed women. anywhere other than your office, pay- True, we sometimes fail, but for the ment for use of the facility, medications, vast majority of patients, it is clearly bene- personnel, and equipment goes to the ficial to attempt the office procedure and FAST TRACK facility, whether an ambulatory surgery avoid anesthesia. Similarly, by avoiding RVUs depend center or a hospital. When we do these abdominal access and general anesthesia procedures in our offices, our reimburse- for sterilization, we are providing a safer on the setting: ment reflects the fact that we are using and more pleasant procedure with rapid ❙ 57.91 your office our office space, exam table, equipment, recovery for our patients. Those few who supplies, and personnel. require a different approach will have ❙ 12.12 other facility When considering where to perform invested little time, energy, effort, or risk if hysteroscopic sterilization, remember that we learn to perform hysteroscopic sterili- no one is paying for our space, personnel, zation in the office setting. ■ and equipment when we are not in the office. Therefore, there is a great advantage REFERENCES in getting our overhead reimbursed when 1. Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert we perform procedures in the office. nonincisional hysteroscopic sterilization. Obstet Gynecol. The total relative value units payable to the 2003;102:59–67. physician for the new CPT code 58565 (hys- 2. Levie MD, Chudnoff SG. Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost teroscopy, surgical, with bilateral fallopian analysis. J Min Invasive Gynecol. 2005;12:318–322. tube cannulation to induce occlusion by 3. Valle RF, Valdez J, Wright TC, Kenney M. Concomitant placement of permanent implants), which Essure tubal sterilization and Thermachoice endometrial is the code for all systems currently under ablation: feasibility and safety.Fertil Steril. 2006;86:152–158. 4. Busfield RA, Farquhar CM, Sowter MC, et al. A randomized study: trial comparing the levonorgestrel intrauterine system and • 12.12 if performed in a facility thermal balloon ablation for heavy menstrual bleeding. • 57.91 if performed in the office BJOG. 2006;113:257–263. Most payers cover hysteroscopic steriliza- Dr. Levy is a consultant to Conceptus, Inc.

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