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.

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)

Retreatment with nafarelin for recurrent endometriosis symptoms: efficacy, safety, and bone mineral density.

OBJECTIVE: To assess the efficacy, safety, and effect on bone mineral density of a 3-month course of retreatment with intranasal nafarelin acetate for recurrent symptoms of endometriosis. DESIGN: Multicenter, open-label, nonrandomized clinical trial. SETTING: Eleven hospital-based and private practices. PATIENT(S): Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with nafarelin. INTERVENTION(S): Nasal nafarelin 200 micrograms twice daily for 3 months. MAIN OUTCOME MEASURE(S): Assessments for dysmenorrhea, dyspareunia, pelvic pain, tenderness, and induration. Measurement of bone mineral density of the lumbar spine. RESULT(S): Improvements from admission to the end of retreatment were significant for dysmenorrhea, pelvic pain, tenderness, induration, and dyspareunia. Three months after retreatment ended, mean symptom scores for dysmenorrhea and pelvic tenderness, although worse than at the end of retreatment, were still significantly better than scores at admission. Mean bone mineral density 3 months after retreatment was 0.56% lower than before retreatment and 1.94% lower than before initial treatment. CONCLUSION(S): Three-month nafarelin retreatment for recurrent endometriosis symptoms was effective and safe.

Injuries to major blood vessels during endoscopy.

Major blood vessel injury is a true emergency during endoscopic procedures. Too often, fear of litigation quashes the opportunity to assess the cause and learn from the experience of others. Frequently, only through a medicolegal review can such events be evaluated. A review of 47 such cases highlighted several key lessons. Proper technique for inserting the Veress needle, laparoscopic cannula, and open cannulas can prevent most accidents. If standard precautions during insertion are breached, safety shields on disposable cannula sleeves may not prevent or reduce the risk of major vessel injury. Distorted anatomy or steep Trendelenburg position may increase the risk. Retroperitoneal hematomas require exploratory laparotomy for proper assessment. Dissections around the great vessels of the pelvis require the same methods and precautions during laparoscopy as during laparotomy.

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%.

Gynecologic endoscopic gas embolism.

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.

Electrosurgical injuries during laparoscopy: prevention and management.

Despite the fact that electrophysics and its application to surgery, in particular endoscopic surgery, is a discreet science, there is little attention paid to the applied principles of the physics involved when surgeons receive their formal training in the technical aspects of surgery. Most training programs consider the discipline of electrosurgery as a skill that is left to the 'hands on' exposure of the student, and that the skills and knowledge of the average professor have been awarded through a 'grandfather' process of credentials. As a result, many myths have been perpetuated over the past decades since William Bovie introduced the first electrosurgical diathermy machine using high frequency radio waves instead of heated instruments (cautery) to destroy human tissue. Electrogenerators, today, have become finely tuned instruments that offer many versatile variables for the contemporary surgeon to harness and deliver, in either a discreet or broad manner, to tissue to obtain a desired effect and outcome.

Qualitative and quantitative analyses of the antibody response elicited by Haemophilus influenzae type b capsular polysaccharide-tetanus toxoid conjugates in adults with IgG subclass deficiencies and frequent infections.

Twenty-one IgG subclass-deficient adult patients with repeated infections of the respiratory tract, were immunized with Haemophilus influenzae type b capsular polysaccharide (HibCP) covalently bound to tetanus toxoid (TT). Specific immunoglobulin and IgG subclasses to HibCP and TT were quantified; the biological activities of HibCP antibodies were also investigated. Most patients showed an antibody response similar to that observed in healthy adults, and the bactericidal activity related to the post-immunization levels of HibCP antibodies. No relation was found between immunoglobulin isotype deficiency, the clinical symptoms and the IgG subclass responsiveness, and no relation was observed between HibCP and TT antibody responses. Our data indicate that some, but not all, patients with recurrent infections and IgG subclass deficiency have an abnormal serum antibody response to polysaccharide and protein epitopes of Hib-TT conjugate vaccine. Analysis of the antibody response after vaccination with HibCP-TT conjugate vaccine did not seem to predict the clinical course of such patients.

Colposcopic documentation. An objective approach to assessing sexual abuse of girls.

Accurate measurements of the genital anatomy of victims of child sexual abuse can be documented with colposcopic photography. Most colposcopies available, however, do not have a built-in measuring grid for medicolegal documentation. Because of the unique optics designed for the colposcope, an accurate comparison can be provided if the measuring tool is photographed in the same focal plane and at the same magnification as the object of concern. Properly labeled slides may then be used as clear evidence in court.

Herpesvirus serology, aberrant specific immunoglobulin G2 and G3 subclass patterns and Gm allotypes in individuals with low levels of IgG3.

One objective of this study was to determine whether IgG3-deficient individuals have an increased frequency of reactivated herpesvirus infections. Serum titres to Epstein-Barr virus (EBV) and human herpesvirus-6 were examined in 10 healthy and in 10 symptomatic persons with serum IgG3 < 0.1 g/l. Atypical titres were found in 16% of the IgG3-deficient individuals. Reactivations of these viruses thus do not seem common in IgG3 deficiency. Antigen-specific IgG responses were also determined. A lowered frequency of IgG3 to an EBV-derived peptide was found only in symptomatic, IgG3-deficient individuals. Levels of IgG2 to a bacterial polysaccharide were lowered in the same group, despite normal serum levels of total IgG2. A functional IgG2 deficiency may contribute to symptoms in IgG3 deficiency. The G3(g) allotype, known to be associated with low total IgG3, dominated in IgG3-deficient persons (13/17) independently of presence or absence of symptoms. A linkage of G3(g) to the G2(n) negative allotype, associated with low IgG2, was equally common irrespective of symptoms. G3(g) and absence of G2(n) seem to be one prerequisite for most of IgG3 deficiency combined with low specific IgG2.