One-year results of the vesta system for endometrial ablation.

STUDY OBJECTIVE: To compare a distensible multielectrode balloon for endometrial ablation with electrosurgical ablation performed by a combined resection-coagulation technique. DESIGN: Randomized, prospective trial (Canadian Task Force classification I). Setting. Eight centers. PATIENTS: Women with menorrhagia validated with a standardized pictorial blood loss assessment chart (PBAC), without intracavitary organic uterine disease, who failed or poorly tolerated medical therapy. Intervention. Results in 122 patients treated by Vesta and 112 treated surgically, evaluable at 1 year, were compared, with success defined as monthly blood loss of less than 80 ml and avoidance of additional therapy. MEASUREMENTS AND MAIN RESULTS: Pretreatment PBAC scores for patients treated by Vesta and resection or rollerball were 535+/-612 and 445 +/- 313, respectively; at 1 year they were 18+/-37 and 28+/-60, respectively. With PBAC below 75 as the definition of success, 86.9% of Vesta-treated patients were successful compared with 83.0% treated by rollerball or resection. Total amenorrhea, defined as no visible bleeding and no use of protective products, was 31.1% and 34. 8%, respectively. None of the outcome comparisons between treatments showed statistical difference. Complications in both groups were few and minor. Most (86.6%) Vesta procedures were carried out with paracervical block with or without intravenous sedation in an office or outpatient setting, compared with 79.7% epidural or general anesthesia for rollerball or resection. CONCLUSION: The Vesta system of endometrial ablation is equally effective and safe as classic resectoscopic methods. Potential advantages include avoidance of fluid and electrolyte disturbance associated with intravasation of distending media, and ability to perform the procedure under local anesthesia in an office setting with less total operating time.

Instrumentation and distention media for the hysteroscopic treatment of abnormal uterine bleeding.

New hysteroscopes and resectoscopes with continuous-flow designs have greatly facilitated diagnostic and therapeutic hysteroscopy. Saline is the ideal distending medium for hysteroscopic procedures in which mechanical or bipolar instruments are used; 5% mannitol may be the safest medium for resectoscopic surgery. Regardless of the medium chosen, careful fluid monitoring is essential.

Interim results of the American Vesta trial of endometrial ablation.

STUDY OBJECTIVE: To compare results of endometrial ablation using the Vesta system compared with resection and rollerball. DESIGN: Multicenter, prospective, randomized, controlled study (Canadian Task Force classification I). SETTING: Private practice and academic center. PATIENTS: Women with menorrhagia documented by menstrual diaries who failed or refused hormonal therapy and who had no major uterine organic lesions. INTERVENTIONS: Vesta endometrial ablation or traditional endometrial resection and rollerball ablation. MEASUREMENTS AND MAIN RESULTS: Both groups achieved excellent control of menorrhagia. CONCLUSION: Vesta is an attractive alternative to traditional methods of endometrial ablation. (J Am Assoc Gynecol Laparosc 6(1):45-49, 1999)

Complications of fluid overload from resectoscopic surgery.

Excess absorption of liquid distending media is one of the most frequent complications of operative hysteroscopy. Although most women recover uneventfully, we are seeing cases of permanent morbidity or death resulting from this complication.

Endometrial ablation using a distensible multielectrode balloon.

The VestaBlate system uses a multielectrode intrauterine balloon as a device to create effective and safe endometrial ablation (EA). The surface of the distensible balloon is impregnated with thermistors and thin, platelike electrodes. It is designed to deliver low-power electroenergy to the endometrium. Unlike the resectoscope techniques that require nonelectrolytic fluids for uterine distention, moving electrodes at high power outputs, and other variables that are operator dependent, the VestaBlate is computer controlled using a standard type electrosurgical generator. A respiratory enzyme stain, nitroblue tetrazoleum, was used to determine the extent and depth of tissue necrosis to a myometrial depth of 2 to 4 mm with uniform destruction of tissue with power setting at 45 W for a 4-minute application of energy. Sixty-nine patients have been treated, with 45 followed for at least 3 to 9 months. The amenorrhea rate is 40%; the oligomenorhea-hypomenorrhea rate is 49%.

Documentation in endoscopy.

The use of video monitoring and imaging techniques have enhanced endoscopic documentation. Conventional photographic techniques using 35-mm photography produce excellent quality images but are cumbersome for routine use. Electronic images can be recorded on videotape or printed, and they can be stored electronically on computer or disk.

Abnormal uterine bleeding. Accuracy of vaginal probe ultrasound in predicting abnormal hysteroscopic findings.

OBJECTIVE: To determine the accuracy of vaginosonography in predicting the presence of abnormal intrauterine findings at hysteroscopy in women presenting with abnormal uterine bleeding. STUDY DESIGN: Two hundred thirty-eight women between the ages of 25 and 75 were evaluated for abnormal uterine bleeding by a combination of vaginal probe ultrasound, hysteroscopy and suction curettage. Ultrasound findings were classified as normal, abnormal or equivocal, and hysteroscopic findings as normal or abnormal. The ability of findings on ultrasound to predict a normal or abnormal hysteroscopic examination was evaluated. RESULTS: Ultrasound examination was normal, equivocal and abnormal in 57 (24%), 78 (33%) and 103 (43%) patients, respectively. If equivocal scans are excluded, ultrasound had a positive predictive value of 87%, negative predictive value of 89%, sensitivity of 94% and specificity of 89%. If equivocal scans are considered abnormal, the positive predictive value of an abnormal ultrasound examination was 75%, negative predictive value was 89%, sensitivity 96% and specificity 53%. Vaginosonography detected 99% of submucous myomas and 89% of endometrial polyps. CONCLUSION: Normal and abnormal vaginal probe ultrasound examination of the uterus is effective in predicting the presence or absence of endometrial pathology as determined by hysteroscopy and suction curettage. Vaginal probe ultrasound is an excellent screening examination for the presence of intrauterine pathology and can assist in planning further evaluation and treatment.

Laparoscopic bilateral pelvic and paraaortic lymph node sampling: an evolving technique.

OBJECTIVE: Reports describing laparoscopic lymph node sampling in patients with gynecologic malignancies have yet to describe a method to sample left-sided aortic lymph nodes that has been successful in a large series of patients. We submit our experience with evolving techniques that allow for excellent visualization and resection of both left and right aortic and pelvic lymph nodes. STUDY DESIGN: Forty patients with gynecologic malignancies underwent laparoscopy for surgical staging. Thirty-five of the patients were completely staged laparoscopically with minimal blood loss. The average number of lymph nodes sampled was 27.7 (range 14 to 35). RESULTS: Five patients required laparotomy, two to control bleeding, two to remove unsuspected intraabdominal disease, and one because of equipment failure. Four patients were rehospitalized within 30 days of surgery, two with small bowel obstructions resulting from herniation of the intestine through 12 mm trocar sites and two others with deep vein thromboses. CONCLUSION: These preliminary results demonstrate an ability to complete surgical staging in patients with gynecologic malignancies by means of specific endoscopic techniques. However, there remains a need for continued evaluation of these techniques and the associated morbidities.

Hysteroscopic treatment of menorrhagia associated with uterine leiomyomas.

OBJECTIVE: To determine the effectiveness of hysteroscopic treatment of menorrhagia associated with uterine leiomyomas. METHODS: Fifty-one women with uterine myomas were treated for menorrhagia by hysteroscopic resection with or without endometrial ablation. Patients were followed for 1-5 years after treatment. RESULTS: The mean number of pads used during the heaviest day of menses decreased from 17.8 before treatment to 6.8 after treatment (P < .005) in women undergoing resection only, and from 21.4 to 1.7 pads per day in women whose treatment included endometrial ablation (P < .001). Two-thirds of the women who underwent ablation were completely amenorrheic after the procedure. Both groups experienced significant decreases in dysmenorrhea. Three patients subsequently underwent hysterectomy after hysteroscopic treatment, and one required a repeat hysteroscopic procedure. CONCLUSION: Hysteroscopic treatment of menorrhagia associated with uterine myomas can be effective in carefully selected patients.

Uterine surface temperature changes caused by electrosurgical endometrial coagulation.

To assess the risk for transmural thermal injury to abdominal viscera during electrosurgical ablation of the endometrium, thermocouples were laparoscopically directed to the surface of the uterus at the time of endometrial ablation. A 2- or 5-mm ball, or a barrel electrode directed through a urologic resectoscope was placed in the cornual area, and current varying from 50 to 150 W of unmodulated ("cutting") or modulated ("coag") current was applied for five seconds without moving the electrode. The resultant temperature rise of the uterine serosa did not exceed 6 degrees C.

High-power Nd:YAG laser ablation of the endometrium.

Nd:YAG laser ablation of the endometrium has become an established procedure for the treatment of menorrhagia. Early studies utilized only half the 100-120 W available from commercially produced lasers. A preliminary in vitro study was done to measure the depth of coagulation caused by the Nd:YAG laser. Fifty watts applied with the contact or noncontact technique reached a depth of 3-4 mm, while 4-5 mm was reached using 100-120 W in the noncontact mode. Thirteen patients underwent endometrial ablation using the Nd:YAG laser at 100-120 W. The mean operating time was 31 minutes. All the patients were available for follow-up, and all had excellent results.

Uterine surface temperature changes caused by endometrial treatment with the Nd:YAG laser.

The report of a bowel injury's occurring during Nd:YAG laser ablation of the endometrium without associated uterine perforation has raised the question of the safety of the procedure. The fibers used during the initial study on temperatures caused by Nd:YAG laser treatment of uterine tissue were placed directly in contact with the tissue. The results may not be applicable to a noncontact technique. Three patients underwent measurement of surface temperature of the uterus during ablation with the Nd:YAG laser using a noncontact technique. The temperatures were within acceptable ranges in two of the patients but reached potentially dangerous levels in the third. In vitro measurements of temperatures in uterine tissue obtained from fresh hysterectomy specimens were made using fine thermocouples. The temperature rise at 10 mm was greater per joule of delivered energy at 55 W than at 95. The temperature rise varied inversely with the tissue depth when the laser was applied in a continuous fashion with a noncontact technique. When the laser was applied continuously, the temperature rise at a depth of 8 mm was significantly greater than at 10 mm. Precise knowledge of the thickness of the uterine wall may be the limiting factor in determining the safety of the procedure.

Depth of endometrial coagulation with the urologic resectoscope.

There is growing interest in using the urologic resectoscope for endometrial ablation, but the actual depth of tissue destruction is unknown. A preliminary in vitro study measured the depth of visible coagulation produced when various waveforms of high-frequency current were applied to tissue using the "rollerball" electrode of the resectoscope. Tissue necrosis caused by high-frequency electrical energy is not immediately apparent: several days must elapse before the true extent of the damage can be seen. To study it, the uterus from a woman who was planning to undergo a hysterectomy was treated with the resectoscope four days prior to surgery. The depth of tissue destruction caused by 19 and 59 W of "cutting" current and by 28 and 57 W of "coagulating" current was 1.5, 2.7, 6.1 and 1.8 mm, respectively. A second patient underwent a hysterectomy 48 hours after resectoscopic endometrial ablation. There was no endometrium remaining, and coagulation extended 2-3 mm into the myometrium. Visual effects on the surface do not predict actual tissue destruction, so further in vivo studies will be necessary in order to obtain consistent clinical results.

Laser treatment of cervical intraepithelial neoplasia in an office setting.

One hundred eighty-six patients underwent carbon dioxide laser treatment of cervical intraepithelial neoplasia. Both vaporization and excisional procedures were performed in an office setting without difficulty. Thirty-nine patients (36.4%) had grade 1, 38 (35.6%) had grade 2, and 30 (28%) had grade 3. Among 107 patients followed up for at least 6 months, there were two treatment failures (5.1%) in the grade 1 group and no treatment failures for grades 2 and 3. The overall success rate for all grades of cervical intraepithelial neoplasia was 98% for a single laser treatment. Our ability to use the laser to excise a specimen, as well as to treat large and endocervical lesions, allowed the office treatment of many patients who would otherwise have required hospitalization.

Conization of the cervix with the CO2 laser as an office procedure.

Conization of the cervix is usually done under general anesthesia in an operating room. The use of the CO2 laser has been shown to reduce the high morbidity associated with cervical conization, but, like cold-knife conization, laser excisional procedures are still usually done in an operating room under general anesthesia. Forty-one patients underwent conization of the cervix with the CO2 laser in an office setting. The procedure was well tolerated, and intraoperative bleeding was not a problem. Two cases of delayed postoperative bleeding were treated on an outpatient basis. The ability to perform cervical conization in an office setting offers significant advantages.