We evaluated the vessel-sealing ability of one application of a pulsed plasma kinetic (PK) electrosurgical device on skeletonized vessels up to 7 mm in diameter to withstand sustained pressure of 300 mm Hg using bench and animal models. Forty-six porcine specimens and 66 abattoir vessels (112 total) were pressure tested after sealing with a pulsed PK system. Of these, 108 (96%) met the criterion of 300 mm Hg pressure held for 10 seconds without leaking. The PK system open forceps effectively closes vessels and maintains closure at a pressure level sufficient for clinical use. The device is more effective than clips, sutures, and staples.
The true prevalence of pulmonary lymphangioleiomyomatosis (LAM) in patients with tuberous sclerosis complex (TSC) is unknown. The prevalence of LAM, radiological features, and lung function in patients with TSC was measured. The presence of LAM, as defined by the presence of cysts by high-resolution chest computed tomography (HRCT) scan, was determined in patients with TSC without prior pulmonary disease (Group 1). To determine the significance of early detection, severity of disease in screened patients (Group 1) was compared with that in patients with TSC with a prior diagnosis of LAM (Group 2). Forty-eight patients with TSC and no prior history of LAM were screened. Of the 38 females, 13 (34%) had LAM; LAM was absent in males. Lung function was preserved in patients with TSC who were found to have LAM by screening. In patients previously known to have LAM, FEV(1) and DL(CO) correlated inversely with severity of disease as assessed by CT scan. The prevalence of LAM in women with TSC was 34%, approximately 10-fold that previously reported, consistent with a large hitherto unrecognized subclinical population of patients at risk for pulmonary complications.
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 1).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 roller-ball 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 intra venous 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.
Safety and outcome of surgical procedures are clearly linked to adequate training. The criteria suggested below are minimal requirements and not absolute requirements as determined by the Board of Trustees of the American Association of Gynecologic Laparoscopists. Surgeons are responsible for obtaining adequate training. Surgeons should not request privileges for procedures or the use of new technologies in which they have not received adequate training. This is especially true when new technologies are used. The burden for satisfying the adequacy of training and surgical competence of the surgeon before allowing direct patient care ultimately falls on the hospital/facility medical staff. Physicians seeking hysteroscopic training should: a. Be board eligible/certified in gynecology, b. Have unsupervised gynecologic privileges for patient care, OR c. Be in an accredited residency program in obstetrics and gynecology. The components of hysteroscopic training ideally will include: a. Didactic training. b. Hands-on laboratory training. c. Case observation (highly recommended). d. Preceptorship (highly recommended). The didactic portion should initially include diagnostic and operative hysteroscopy and be a minimum of 6 hours. It should be a CME-approved program and include: 1. Uterine anatomy 2. Options of distention media 3. Management of distention media 4. Energy sources 5. Instrumentation 6. Surgical indications and techniques for: a. diagnostic hysteroscopy b. adhesiolysis c. metroplasty d. polycystic ovary e. fibroid resection/vaporization f. endometrial ablation 7. Prevention and management ofhysteroscopic complications.
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.
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.
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%.
OBJECTIVE:To alert gynecologic surgeons to the risk of room air embolism during endoscopy.DESIGN:Case reports.SETTING:Medico-legal consultations.PATIENTS:Five women having endoscopic procedures.INTERVENTIONS:Endoscopy followed by emergency resuscitative measures.RESULTS:Morbidity and mortality.CONCLUSIONS:The risk of room air embolism may be lessened by attention to the operative technique and by monitoring the end tidal carbon dioxide levels.
This study compared the costs of endometrial ablation using the uterine resectoscope to those of hysterectomy in a group of patients treated for abnormal uterine bleeding who were enrolled in a national managed health care organization. The cost of endometrial ablation during the periprocedural period was significantly lower than that of hysterectomy, with much of the difference coming from the hospitalization required for the latter procedure. The postprocedural cost for ablation was higher than for hysterectomy owing to the need for second ablations or hysterectomy in 13 of the 85 ablation patients. Preprocedure costs were not different between ablation and hysterectomy. A reanalysis of the data, however, that excluded patients who required a second ablation or hysterectomy suggested that these additional procedures were responsible for the higher postprocedural costs in the ablation group. Resectoscopic endometrial ablation for the treatment of abnormal uterine bleeding resulted in lower periprocedure costs and lower overall treatment costs to the health plan in the groups studied as compared with hysterectomy. Greater familiarity with the technique of resectoscopic endometrial ablation, improved patient selection for the procedure and the use of appropriate pharmacotherapy for suppressing endometrial growth prior to ablation probably substantially improve the rate of success, reduce postprocedural costs and further enhance the cost advantage of this procedure.
A study was performed to assess the effect of dilute vasopressin on intraoperative bleeding and intravasation of the medium during resectoscopic hysteroscopic surgery. Dilute vasopressin or placebo was injected into the cervical stroma at the commencement of resectoscopic endometrial ablation and/or submucous myomectomy in a prospective, computer-generated, double-blind, placebo study. The operator estimated the intraoperative bleeding. The inflow volume and outflow recovered volume of sorbitol, used as a distending medium, were recorded. Pressures were kept constant with a pump. Operating time was also recorded. In 64 women the mean inflow volume was 5,584 mL (range, 500-27,000), and the mean deficit (intravasation) was 311 mL (range, 0-2,100). The mean surgical time was 37.1 minutes (range, 11-120). The deficit volume was related to the duration of surgery (P = .001) and to total inflow volume (P = .001). Increased operating time and volume infused also increase intravasation. Multivariate analysis showed that patients receiving vasopressin had a 0.36 risk of intravasation (confidence limit, 0.14-0.91) as compared with the placebo. Vasopressin injected intracervically, in conjunction with resectoscopic intrauterine surgery, reduces but does not eliminate intravasation of the medium. It also decreases intraoperative bleeding.
In order to improve the success of endometrial ablation for uncontrolled uterine bleeding, a variety of preoperative agents were utilized. Patients were given either no preparation, progestins, danazol or leuprolide acetate depot as preoperative therapy to determine the best way to increase the incidence of amenorrhea and to decrease the failure rates. The lowest rates were achieved with danazol or no preparation, with amenorrhea rates of 41 and 43%, respectively. The highest rates were obtained with the use of either progestins or leuprolide acetate depot, 61 and 67%, respectively. Progestin use was discontinued early in the study because of side effects, resulting in numbers too low for accurate comparison. We concluded that the use of leuprolide acetate depot in a single-dose regimen resulted in the highest amenorrhea rates, with minimal or no side effects.
Endometrial ablation, rapidly becoming a standard operation for the management of abnormal uterine bleeding, is usually performed for patients between ages 35 and 45. This study reports on the results of resectoscopic endometrial ablation for 26 patients aged 50 and older, followed from 7 to 43 months (average follow-up period, 21 months). Seventeen of the patients were menopausal at the time of the procedure or became menopausal during the follow-up period, with 13 on combined estrogen and progestin therapy and 4 on unopposed estrogen (because of progestin intolerance). Twenty-three of the 26 patients (88%) are amenorrheic, one premenopausal patient has normal periods and none have failed. The fear of hiding glandular tissue that subsequently becomes malignant is discussed and believed to be highly unlikely to occur.
Guest Editor University of Southern California, and Cedars-Sinai Medical Center, Los Angeles, California