Clinical Experience With Contrast Infusion Sonography as an Essure Confirmation Test

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1 ORIGINAL RESEARCH Clinical Experience With Contrast Infusion Sonography as an Essure Confirmation Test Viviane F. Connor, MD Received November 3, 2010, from the Department of Gynecology, Section of Minimally Invasive Gynecology, Cleveland Clinic Florida, Weston, Florida USA. Revision requested November 28, Revised manuscript accepted for publication December 22, The author thanks Denise Fischer, MD, for meticulous efforts collecting the data, Sandra Madueke, MPH, for performing the telephone survey, and Linda Bywalec, RN, for assistance in performing all of the contrast infusion sonographic examinations. The author is a consultant for Conceptus, Inc (Mountain View, CA), but received no financial support for this study. Address correspondence to Viviane F. Connor, MD, Department of Gynecology, Section of Minimally Invasive Gynecology, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL USA. connorv@ccf.org Objectives The purpose of this study was to assess the clinical experience, including the feasibility, safety, compliance, and efficacy, of contrast infusion sonography as an Essure (Conceptus Inc, Mountain View, CA) confirmation test. Methods A retrospective chart review and telephone survey were conducted at an academic multispecialty group. The study participants were women with Essure intervention who underwent contrast infusion sonography, transvaginal sonography, and hysterosalpingography as Essure confirmation tests. The main outcome measures included the feasibility, safety, compliance, and efficacy of contrast infusion sonography as a first-line Essure confirmation test. Results A total of 118 women had successful bilateral Essure placement. Of the 63 who consented to contrast infusion sonography, 53 (84.1%) had proper bilateral placement and tubal occlusion and were encouraged to rely on Essure. Four were suspected of having unilateral tubal patency; hysterosalpingography in 2 confirmed bilateral tubal occlusion, and 2 were noncompliant with second-line hysterosalpingography. Three patients suspected of having unsatisfactory or uncertain placement on initial transvaginal sonography were encouraged to undergo hysterosalpingography in lieu of contrast infusion sonography, which confirmed unsatisfactory placement in 2 and proper placement and occlusion in 1. Three contrast infusion sonographic procedures could not be completed because of technical issues; therefore, contrast infusion sonography was feasible in 95.2% of the patients (60 of 63). No notable adverse events occurred. Only 17 patients were noncompliant with any confirmation test, yielding an overall compliance rate of 86% (101 of 118). No pregnancies occurred during 669 woman-months of follow-up. The average reimbursement for contrast infusion sonography was US$ Conclusions Preliminary clinical data suggest that contrast infusion sonography is a feasible, safe, and accurate Essure confirmation test, which is well accepted by patients. Key Words contrast infusion sonography; Essure; hysterosalpingography; hysteroscopic sterilization; transvaginal sonography T he Essure hysteroscopic sterilization system (Conceptus, Inc, Mountain View, CA) was approved by the US Food and Drug Administration in November Since then, worldwide clinical experience, as determined by review of the literature and the Manufacturer and User Facility Device Experience database, analysis of reports of unintended pregnancy to the manufacturer, as well as personal experience and communications, all corroborate the safety and efficacy data generated in clinical trials. 1, by the American Institute of Ultrasound in Medicine J Ultrasound Med 2011; 30: /11/$3.50

2 The successful bilateral placement rate with the current Essure delivery catheter (ESS305) is 96.9%, 3 and the 5-year effectiveness is 99.74%. 4 Current labeling in the United States for Essure requires hysterosalpingography 3 months after placement to document the proper microinsert position and tubal occlusion. 5 With clinical experience, it has become apparent that hysterosalpingography is not an optimal confirmation test and can be subject to misinterpretation. In fact, 30% of unintended pregnancies after Essure placement have been attributed to misinterpretation of the hysterosalpingography. 6 There are also inherent issues with hysterosalpingography such as poor interobserver reproducibility, 7 variability in the technique, and tubal spasm potentially creating the false impression of proximal tubal occlusion, all of which limit the predictive value of this confirmation test. Logistic issues including inconvenience, exposure to ionizing radiation, cost, and patient discomfort all contribute to suboptimal compliance, which ranges between 12.7% and 81%. 8,9 The purpose of this retrospective chart review with telephone and chart follow-up was to analyze the experience in this institution with an off-label, in-office contrast infusion sonographic procedure as an alternative first-line Essure confirmation test. Materials and Methods Institutional Review Board approval was obtained from Cleveland Clinic Florida. Hysteroscopic sterilization with Essure is the first-line method of permanent birth control for women in this institution and is offered to all women in the absence of a contraindication. On the basis of the safety and efficacy of contrast infusion sonography previously reported, 10,11 subsequent patients with successful, uncomplicated bilateral Essure placement by 3 experienced staff gynecologists in this institution were offered off-label, inoffice contrast infusion sonography as an Essure confirmation test. Patients were also offered hysterosalpingography or transvaginal sonography depending on clinician preference and logistic reasons (such as cost or a confirmation test performed outside this institution). Patients with concomitant endometrial ablation were excluded. Informed consent was obtained, and all patients offered contrast infusion sonography were also offered hysterosalpingography in accordance with the Food and Drug Administration recommendation. No patients refused contrast infusion sonography and requested hysterosalpingography. The technique for contrast infusion sonography has previously been reported, 10 and the only subsequent modifications include omitting the use of prophylactic antibiotics and a nonsteroidal anti-inflammatory drug for an antispasmodic. To briefly review the procedure, initially the Essure microinserts were inspected with transvaginal sonography to confirm the proper bilateral position crossing the interstitial portion of the fallopian tube and the uterine serosal-tubal junction (Figure 1). Once the proper bilateral position was confirmed, contrast infusion sonography was performed in a manner similar to hysterosal - pingography using an intrauterine balloon catheter inserted with sterile technique. The contrast solution infused consists of 1 ml of a perflutren microsphere contrast agent (Definity; Bristol Myers-Squibb Medical Imaging, North Billerica, MA) mixed with 20 ml of normal saline. While focusing on the linear axis of the intramyometrial portion of one microinsert, with low pressure infusion, the presence of real-time flow through and beyond the Essure microinsert was evaluated (Figure 2). With increasing experience, the intratubal portion of the Essure microinsert was increasingly visualized, including the distal tip of the inner coil. This procedure was then repeated on the contralateral side, and with delayed imaging, the cul-de-sac was inspected for the presence of the contrast agent. To maintain consistency with previously reported cases, 3- dimensional reconstruction was not used. All contrastinfusion sonographic procedures were performed by a single gynecologist (V.F.C.). Between April and May 2010, 29 women were contacted by telephone and asked, Have you been relying on Essure for contraception, and if so, have you conceived? An additional 23 electronic medical records were reviewed. The Current Procedural Terminology codes used for billing Figure 1. Echogenic Essure microinsert visualized on sonography extending from the tubal ostia and crossing the intramural portion of the fallopian tube and uterine serosal-tubal junction. 804 J Ultrasound Med 2011; 30:

were 76831 (saline infusion sonohysterography) and 58340 (catheterization and introduction of saline or contrast material for saline infusion sonohysterography), and the International Classification

Results A total of 118 women, ages 25 to 48 years with 0 to 3 deliveries, underwent successful bilateral Essure placement without any concomitant procedure by 3 gynecologists between January 2006 and

3 were (saline infusion sonohysterography) and (catheterization and introduction of saline or contrast material for saline infusion sonohysterography), and the International Classification of Diseases, Ninth Revision, code used was V26.51 (tubal ligation status). Average reimbursement from a range of commercial payers, excluding Medicaid, was calculated. Results A total of 118 women, ages 25 to 48 years with 0 to 3 deliveries, underwent successful bilateral Essure placement without any concomitant procedure by 3 gynecologists between January 2006 and July Overall, the health status of the participants was excellent; however, comorbidities and indications for sterilization included 1 woman each with Parkinson s disease, sickle cell disease, neurofibromatosis, and a personal history of thyroid cancer. Methods of backup contraception during the first 3 months after Essure placement included abstinence, condoms, vaginal contraceptive rings, oral contraceptives, and injectable medroxyprogestereone acetate. Contrast infusion sonography was planned as the firstline confirmation test in 63 patients and completed in 57 patients (Figure 3). There were no serious adverse events, and when present, pelvic cramping secondary to uterine distension resolved by the end of the procedure. There were no vasovagal reactions, allergic reactions, or shortness of breath due to the contrast agent. Although no prophylactic antibiotics were provided, there were no pelvic infections. In 3 of 63 patients (4.7%), contrast infusion sonography could not be performed for technical reasons: 2 secondary to an inability to localize the microinserts as a result of uterine anteflexion and 1 due to cervical stenosis prohibiting insertion of the intrauterine catheter. The 2 patients with microinsert nonvisualization both had hysterosalpingography documenting proper placement and bilateral tubal occlusion. The patient with cervical stenosis had proper placement on transvaginal sonography and as a result elected to rely on Essure. Of the 57 completed contrast infusion sonographic studies, 53 (93%) revealed proper microinsert location crossing the uterine serosal-tubal junction and bilateral tubal occlusion. Four patients with proper placement had definite or equivocal tubal patency (Figures 4 and 5). Of these, 2 were compliant with second-line hysterosalpingography and had tubal occlusion documented, and the remaining 2 were noncompliant. Three women had suspected unsatisfactory or equivocal placement on initial transvaginal sonography, prompting cancellation of the contrast infusion sonography and referral for hystero - salpingography. All were compliant with second-line hysterosalpingography; proximal placement, distal placement, and proper placement were identified. Both women with unsatisfactory placement elected to proceed with another form of birth control. Thirty-one patients had a first-line hysterosalpingographic confirmation test. Seven additional patients had first-line transvaginal sonography, 1 at her 4- week postoperative visit because of difficult placement, and sonography revealed suspected expulsion into the cul de sac (Figure 6), which was confirmed with second-line hysterosalpingography. Seventeen patients were noncompliant with any confirmation test; therefore, overall compliance with a first-line confirmation test was 85%. Figure 2. Echogenic contrast agent adjacent to the proximal end of the Essure microinsert. Figure 3. Patient flow chart showing Essure microinsert confirmation test results. CIS indicates contrast infusion sonography; HSG, hystero - salpingography; and TVU, transvaginal sonography. J Ultrasound Med 2011; 30:

woman-months of reliance. Three women had no follow-up at all; 7 had no follow-up in the gynecology department; and 2 subsequently underwent hysterectomies for reasons unrelated to Essure.

4 No pregnancies were reported over 500 womanmonths of reliance in 29 women contacted by telephone for follow-up. Of the additional 23 electronic medical records reviewed, no pregnancies were documented in 11 women who subsequently were seen in the gynecology department, documenting an additional 169 woman-months of reliance. Three women had no follow-up at all; 7 had no follow-up in the gynecology department; and 2 subsequently underwent hysterectomies for reasons unrelated to Essure. No documentation of pregnancy was identified. All patients had private insurance through a variety of commercial carriers. The average total reimbursement of the first 40 cases using Current Procedural Terminology codes and was US$ Discussion The Essure permanent birth control system has been available in the United States since November Through 2008, 259,746 kits had been delivered worldwide, and 305 pregnancies had been reported, consistent with ageadjusted effectiveness of 99.85%. 12 Analysis of many of these pregnancies reveals that the root cause can often be attributed to deviation from the protocol, 13 suggesting that the microinserts are highly effective when located in the proper position. Because hysteroscopic sterilization is rapidly replacing laparoscopic sterilization, 14 the need for determining the most accurate, safe, and cost-effective confirmation test is growing. This trend will accelerate as younger physicians who are more likely to perform hysteroscopic sterilization enter into practice, 15 patient demand for minimally invasive options increases, and additional systems for hysteroscopic sterilization become available in the future. Figure 4. Contrast agent in the fallopian tube showing patency. With clinical experience in the United States since 2002, it has become apparent that hysterosalpingography as a first-line confirmation test has several drawbacks. First and foremost is suboptimal compliance, which ranges from 12.7% to 81%. 8,9 There is also variable experience and familiarity with interpretation of hysterosalpingography as a confirmation test, resulting in misinterpretation, which has been identified as the root cause of 30% of the unintended pregnancies. 6 Variability in the technique when performing low-pressure hysterosalpingography, including insufficient or excessive intrauterine pressure during dye instillation, likely influences the hysterosalpingographic results as well. In an effort to address several of these issues, as previously described, hysterosalpingographic contrast-enhanced sonography was adapted for use as an Essure confirmation test in lieu of hysterosalpingography, anticipating that an inoffice, sonographically based confirmation test may be more readily accepted by patients. Review of the ongoing experience in this institution over an additional 4 years suggests that outcomes are favorable. No serious adverse events occurred, and compliance was higher than reported with hysterosalpingography in several institutions. Most importantly, there have been no reported pregnancies. Because of the physics of ultrasound, the nickel-titanium microinserts are highly echogenic, and the thickness and hypoechoic nature of the myometrium allow for quick identification of the microinsert and subsequent assessment of the soft tissue relationship (Figure 1). If the microinsert is not crossing the uterine serosal-tubal junction, the sonographer can easily identify an unsatisfactory microinsert location before infusion of the contrast agent and then refer the patient for confirmatory hysterosalpingography. The microinserts could not be identified in only 3.1% of cases (2 of 63) because of Figure 5. Highly echogenic contrast agent located adjacent to the ovary after infusion, indicating tubal patency. 806 J Ultrasound Med 2011; 30:

uterine anteflexion and soft tissue dystocia as a result of obesity. Two of 3 cases of suspected unsatisfactory placement on scout sonographic examinations were confirmed on hysterosalpingography.

5 uterine anteflexion and soft tissue dystocia as a result of obesity. Two of 3 cases of suspected unsatisfactory placement on scout sonographic examinations were confirmed on hysterosalpingography. Although not objectively evaluated, subjectively, patients have been more comfortable proceeding with a confirmation test in the familiar setting of the gynecologist s office, and contrast infusion sonography induces less cramping than hysterosalpingography. With ongoing experience, it has become possible to routinely check for symmetry of the microinserts and evaluate the linear axis of each, allowing for identification of the uterine serosal-tubal junction and frequently the distal end of the inner coil, providing the ability to check for real-time flow of dye contrast beyond the outer coil of the microinsert in the fallopian tube. Limitations of this study included the inability to assess interobserver variability and misinterpretation of contrast infusion sonography because only 1 physician performed all of the contrast infusion sonographic tests. Although only 29 patients were contacted by telephone and surveyed regarding pregnancy, many more of the patients continue to seek care at this multispecialty facility, and it is likely that any pregnancy within this group would have been reported. No documentation of pregnancy was identified on additional chart review. This retrospective telephone survey could have been subject to recall bias, although it is likely that an unintended pregnancy would not be forgotten. With no reported pregnancies and a small sample size, statistical analysis was not possible. Because Essure is highly effective at preventing pregnancy, a large sample size would be required, ideally in a prospective multicenter trial, to demonstrate statistical significance. Figure 6. Intraperitoneal Essure microinsert identified on transvaginal sonography. Note the lack of any identifiable surrounding soft tissue structure. In conclusion, ongoing clinical experience with contrast infusion sonography confirms that it may be a safe, feasible, cost-effective, and accurate alternative to hysterosalpingography as a first-line Essure confirmation test for patients with uncomplicated placement. No serious adverse events occurred, and patients with a suspected unsatisfactory microinsert position or tubal patency should be referred for hysterosalpingography. The expense, exposure to ionizing radiation, and risk of an allergic reaction to an iodine-based dye incurred with hysterosalpingography were avoided in 57 of 63 cases (90.4%). Compliance was higher than that reported from several institutions for hysterosalpingography, suggesting that this confirmation test is well received by patients. No pregnancies occurred during 669 woman-months of follow-up. References 1. Kerin JF, Cooper JM, Price T, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod 2003; 18: Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003; 102: Conceptus, Inc. Conceptus Receives FDA Approval on Essure s Bilateral Placement Rate to 96.9%: Additional Data Supports Improved Average Hysteroscopic Time to 9 Minutes [press release]. Mountain View, CA: Conceptus, Inc; May 18, Conceptus, Inc. Essure Permanent Birth Control System. Mountain View, CA: Conceptus, Inc. Premarket approval application PO20014, suppl 9. Approved July 12, Conceptus, Inc. Essure Permanent Birth Control System [instructions for use, United States]. Mountain View, CA: Conceptus, Inc; Connor VF. Essure: a review six years later. J Minim Invasive Gynecol 2009; 16: Glatstein IZ, Sleeper LA, Lavy Y, et al. Observer variability in the diagnosis and management of the hysterosalpingogram. Fertil Steril 1997; 67: Shavell VI, Abdallah ME, Diamond MP, Kmak DC, Berman JM. Post- Essure hysterosalpingography compliance in a clinic population. J Minim Invasive Gynecol 2008; 15: Tagoe UJ, Della Badia C, Chaudhari A. Postoperative compliance with a 3-month hysterosalpingogram after Essure hysteroscopic tubal occlusion [abstract]. J Minim Invasive Gynecol 2006; 13(suppl):S Connor VF. Contrast infusion sonography to assess microinsert placement and tubal occlusion after Essure. Fertil Steril 2006; 85: Connor VF. Contrast infusion sonography in the post-essure setting. J Minim Invasive Gynecol 2008; 15: J Ultrasound Med 2011; 30:

6 12. Munro MG, Casas L. Retrospective analysis of 2008 worldwide pregnancy reports in women with Essure micro-inserts [abstract]. J Minim Invasive Gynecol 2009; 16(suppl):S Kerin JF, Levy BS. Ultrasound: an effective method for localization of the echogenic Essure sterilization micro-insert: correlation with radiologic evaluations. J Minim Invasive Gynecol 2005; 12: Shavell VI, Abladdah ME, Shade GH Jr, Diamond MP, Berman JM. Trends in sterilization since the introduction of Essure hysteroscopic sterilization. J Minim Invasive Gynecol 2009; 16: Apte DM, Jacobs AJ, Santandreu O, Primavera L. Factors affecting acceptability of hysteroscopic sterilization to providing physicians [abstract]. J Minim Invasive Gynecol 2009; 16(suppl):S110 S J Ultrasound Med 2011; 30:

ESSURE A RESOURCE FOR CODING

ESSURE A RESOURCE FOR CODING ESSURE REIMBURSEMENT GUIDE A RESOURCE FOR CODING INDICATION Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of fallopian tubes. IMPORTANT