24 GYNECOLOGY APRIL 2009 • OB.GYN. NEWS Little Data on CHD Risk Patient Compliance With In Bilateral HSG After Essure Is High

ARTICLES BY DOUG BRUNK One of three studies involving natural- L AS V EGAS — Patient compliance ization in his former private ob.gyn. ly menopausal women did show a slight with the recommendation for a hys- practice in Allentown, Pa., from De- L AS V EGAS — A systematic review of increased risk of CHD, with a hazard ra- terosalpingogram after Essure hys- cember 2003 through May 2008. the medical literature yielded mixed re- tio of 1.16 (Circulation 2005;111:1462-70). teroscopic can be high in Of those patients, 128 were at least sults concerning the effects of bilateral “But in a subsequent analysis that ac- the private practice setting, according 3 months post procedure and 2 were oophorectomy on the risk of coronary counted for the effect of all demographic to Dr. Larry R. Glazerman, who not, said Dr. Glazerman, who is now heart disease. and cardiovascular risk factors like hyper- tracked compliance in a chart review director of minimally invasive surgery “There’s been a concern that bilateral tension, diabetes, and smoking, there was of his practice. in the department of obstetrics and oophorectomy may increase the risk of no statistically significant increased risk of “Since the introduction of Essure in gynecology at the University of South coronary heart disease because estrogen coronary heart disease,” Dr. Jacoby said. 2003, physician uptake has been sub- Florida, Tampa. Of the 128 patients, deprivation might accelerate the rate of One of two studies involving pre- stantially less than expected, despite 116 (91%) underwent hysterosalpin- atherosclerosis,” Dr. Vanessa Jacoby said at menopausal women, the Nurse’s Health the obvious advantages in terms of no gography, and 100 (86%) of those 116 the annual meeting of the AAGL. Study, reported an increased risk of CHD, incisions, no general anesthesia, and showed bilateral tubal occlusion on Dr. Jacoby and her associates sought to with a relative risk of 2.2 (N. Engl. J. Med. no hospital their first hys- identify all of the available related litera- 1987;316:1105-10). “That was only in stay,” Dr. Glaz- Concern about terosalpin- ture on PubMed and Embase between women who never took estrogen follow- erman said at noncompliance gogram. Of the 1966 and 2007, all related abstracts that ing bilateral oophorectomy, and only in an the annual with HSG should 16 patients who were presented at the annual clinical meet- analysis that accounted for age and smok- meeting of the not deter failed their ini- ing of the American College of Obstetri- ing,” she said. “But in a subsequent analy- AAGL. “One of physicians from tial HSG, 13 cians and Gynecologists between 1996 sis that accounted for other cardiovascular the expressed offering the had document- and 2006, and reference lists from the re- risk factors such as obesity, hypertension, concerns is that Essure procedure. ed tubal occlu- trieved articles. Studies were included if and diabetes, there was no increased risk.” the [Food and sion on their they compared women who had bilateral The other study involving premenopausal Drug Adminis- DR. GLAZERMAN second HSG; 2 oophorectomy with a to women found a significantly increased risk tration] requires had a previous women who had a hysterectomy and ovar- of CHD in women aged 40-44 years who a 3-month confirmatory hysterosalp- unilateral ; and 1 had ian conservation, naturally menopausal had undergone hysterectomy and bilateral ingogram [HSG] after the procedure, unilateral placement, and subse- women, premenopausal women, or pre- oophorectomy, but not in women aged 45 before the patient is allowed to rely on quently conceived. menopausal women with no history of years and older (Ann. Intern. Med. the device for contraception. In my Based on the findings, Dr. Glazer- hysterectomy or bilateral oophorectomy 1978;89:157-61). One of two studies involv- personal discussions with physicians, man concluded that concern about but unreported or unknown menopausal ing women with no history of hysterecto- I hear all the time that ‘my patients noncompliance with HSG “should not status. The primary outcome was fatal or my or bilateral oophorectomy but unre- don’t want to come back for the HSG. deter physicians from offering hys- nonfatal coronary heart disease. ported or unknown menopausal status They’d rather know right away that teroscopic sterilization. The way I pre- Nearly 2,000 abstracts were reviewed, showed a significantly increased risk of they are sterile.’ ” sent the Essure procedure to patients said Dr. Jacoby of the department of ob- CHD, but only in women younger than age Dr. Glazerman disclosed that he is a is like this: ‘If they have a laparoscopic stetrics, gynecology, and reproductive sci- 60 years (Acta. Obstet. Gynecol. Scand. preceptor, speaker, and consultant for tubal failure (a rate of 0.5%-1%), the ences at the University of California, San 1981;106 [Suppl.]:11-5). Conceptus Inc., which developed the only way they know if it fails is if they Francisco. From these, 16 observational A limitation of the analysis, she said, is Essure procedure. He is also a precep- get pregnant. On the other hand, if studies were reviewed in full and 7 were that the observational studies used “are in- tor for Karl Storz Endoscopy–America they have a hysterosalpingogram af- used in the final analysis. No randomized herently limited by the potential effect of Inc. ter the Essure that shows bilateral oc- trials were located. confounding on the outcome. To that To determine the rate of compli- clusion, there’s a pregnancy rate of Two studies involving women with a end, our goal is to implement a random- ance with the FDA recommendation less than 1 in 200,000 cases. My pa- hysterectomy and ovarian conservation ized trial of bilateral oophorectomy so we for the hysterosalpingogram, Dr. tients seem to like that. In addition, showed no significant increased risk of can have the highest-quality evidence to Glazerman studied the medical charts they like the fact that there’s no hos- coronary heart disease following bilateral guide our clinical practice for this very of 130 consecutive patients who un- pital stay, no incision, and no gener- oophorectomy. common clinical question.” ■ derwent Essure hysteroscopic steril- al anesthesia.” ■ Paracervical Block Has Little Effect on Essure Placement

L AS V EGAS — Paracervical block de- lege of Medicine, New York. “None fo- of pain during the procedure. searchers placed the speculum into the creases the pain associated with cervical cusing on Essure were randomized, Dr. Chudnoff reported that there were , prepped the area, injected 1 cc of manipulation, but has little effect on the placebo-controlled studies.” three unsuccessful placements in each lidocaine into the anterior lip of the pain associated with hysteroscopic place- To determine if paracervical block at group. , and placed a single-tooth tenac- ment of the Essure device for sterilization the time of hysteroscopic placement of The average pain score for hystero- ulum on the anterior lip. or on the technical success of the place- the Essure device provides clinical pain scope placement into the cervix was 4.5 Patients received 5 cc of 1% lidocaine ment, a single-center randomized trial relief, he and his associates randomized in the saline group, compared with 2.6 in or saline injected at the 4 o’clock location showed. 40 women to receive 10 cc of 1% lido- the lidocaine group, a difference that on the cervix and 5 cc of 1% lidocaine or “The management of the pain should caine, and another 40 to receive 10 cc of was statistically significant. Similar find- saline injected at the 7 o’clock location. be individualized between the patient normal saline, as a paracervical injection ings were noted for transversing the ex- The researchers allowed for a 3- to 5- and the physician, and attention to tech- prior to the start of the procedure. The ternal orifice of the cervix uteri (3.8 for minute rest period to permit the block to nique and patient reassurance are key to 10-cc dose of lidocaine “is the amount the saline group vs. 1.5 for the lidocaine set before the introduction of the hys- successful in-office placement of Essure we used in a pilot study and is the rec- group) and for transversing the internal teroscope and subsequent placement of devices,” Dr. Scott Chudnoff said at the ommended dose to be used based on the orifice of the cervix uteri (4.1 vs. 1.8). the Essure device. annual meeting of the AAGL. clinical indications for lidocaine in a However, there were no significant dif- All subjects and investigators were Although several researchers have per- paracervical block,” Dr. Chudnoff said in ferences between the saline group and blinded to the treatment groups, and no formed assessments of pain during hys- a later interview. the lidocaine group in the average pain errors in randomization occurred. The teroscopy, as well as during the Essure Patients were asked to complete the 8- scores for placement of the Essure device average age of the patients was 35 years, procedure, “most of these studies have point Visual Analog Scale to assess pain (3.7 vs. 3.2). and 62% were Hispanic. significant methodological flaws, or they during ketorolac (Toradol) injection and For the procedures, which were per- Dr. Chudnoff disclosed that one of his focused on diagnostic ,” at the conclusion of the placement of the formed between March 2007 and March associates, Dr. Mark Levie, serves on the noted Dr. Chudnoff of the department Essure device. 2008, all patients also received 60 mg IM medical advisory board and is on the of obstetrics and gynecology and Patients also used the VAS to report ketorolac in the buttocks before the pro- speakers bureau for Conceptus Inc., which women’s health at Albert Einstein Col- the average level and the highest level cedure to reduce tubal spasm. The re- developed the Essure procedure. ■