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Update.Finalrev 8/21/06 2:53 PM Page 26 OBG_09.06_Update.finalREV 8/21/06 2:53 PM Page 26 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/nick- el 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- CONTINUED 26 OBG MANAGEMENT • September 2006 For mass reproduction, content licensing and permissions contact Dowden Health Media. OBG_09.06_Update.final 8/18/06 11:37 AM Page 29 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. CONTINUED www.obgmanagement.com September 2006 • OBG MANAGEMENT 29 OBG_09.06_Update.final 8/18/06 11:37 AM Page 30 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%
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