Validation of the Patient Global Impression scales for use in detrusor overactivity: secondary analysis of the RELAX study.

OBJECTIVE: To assess construct validity of the Patient Global Impression scales (Severity [PGI-S], Bother [PGI-B] and Improvement [PGI-I]) for symptoms of detrusor overactivity (DO). DESIGN: Secondary analysis of a randomised trial of onabotulinum toxin A. SETTING: Eight UK urogynaecology departments. POPULATION: A total of 240 women with DO refractory to medical treatment randomised to receive 200 iu onabotulinum toxin A or placebo in the RELAX trial and followed up for 6 months. MAIN OUTCOME MEASURES: Urinary diaries and disease-specific quality of life (QoL) questionnaires were completed at baseline and during follow up. Discriminatory ability of the PGI-S, PGI-B and PGI-I scales to identify symptom severity and change in severity was assessed by comparing mean diary and QoL outcomes across the response categories, analysed by one-way analysis of variance. RESULTS: Data were available from 237 women (98.8%) for validation of PGI-S and PGI-B at baseline, and 192 women (80%) at 6 weeks follow up for validation of PGI-I. Leakage episodes (P = 0.01), urgency episodes (P = 0.019), urgency severity (P = 0.012), and QoL scores (all P < 0.001) were greater in women with more severe problems on PGI-S. Similar results were seen for PGI-B: leakage (P = 0.051), urgency episodes (P < 0.001), urgency severity (P < 0.001), and QoL scores (all P < 0.001). PGI-I responses demonstrated significant relationships with size of change of all variables (P < 0.001). The generic instrument EQ-5D had weaker relationships (PGI-S, P = 0.09; PGI-B, P = 0.004; PGI-I, P = 0.06), suggesting that it was less sensitive. CONCLUSIONS: The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women with detrusor overactivity.

Evaluation of urogynaecology care of an elderly population in a specialist urogynaecology centre.

The ageing population of the UK means that demand for urogynaecology services is expected to increase substantially, particularly in patients aged over 65 years. To assess service provision and predict future needs, we reviewed the demographic profile and service requirements of elderly patients referred to our urogynaecology service. We performed a retrospective review of case notes of 125 patients over 65 years of age who attended our urogynaecology clinic within a 6 month period, including comorbidity scoring using a validated instrument. A substantial proportion (56%) of patients did not require hospital-based management, and none of the patients had an adult comorbidity evaluation (ACE-27) score >2. Hence, we recommend assessing patients using the ACE-27 score and not on chronological age alone. A restructuring of urogynaecology services towards better access to community-based clinics is required to reflect the treatment needs of the patient population. This would be in line with national continence care guidance.

Percutaneous closure of the small patent ductus arteriosus using occluding spring coils.

OBJECTIVES: This report summarizes our experience with the use of occluding spring coils to close the small patent ductus arteriosus. BACKGROUND: Several patent ductus arteriosus occluders (most notably the Rashkind device) have been developed and studied. Occluding spring coils have been used to close abnormal vessels and vascular connections. We previously reported the use of occluding spring coils to close the small patent ductus arteriosus in a small group of patients. This report describes our series of patients having patent ductus arteriosus closure with occluding spring coils. METHODS: Between June 1990 and June 1993, 30 patients underwent cardiac catheterization to have patent ductus arteriosus closure by occluding spring coils. Selection criteria were age > 6 months and narrowest patent ductus arteriosus internal dimension < or = 3.0 mm by color flow imaging. Definitive selection was based on review of aortograms performed at catheterization. A 5.2F coronary catheter was used to deliver one or two standard occluding spring coils. A loop was delivered in the main pulmonary artery, and the remainder of the coil was delivered across the patent ductus arteriosus and into the aortic diverticulum. Patent ductus arteriosus closure was confirmed by aortography or color flow imaging, or both. Follow-up after coil placement occurred at 6 weeks and 6 months and included two-view chest radiography, echocardiography and color flow imaging. RESULTS: Of the 30 patients, 29 had successful implantation by one (27 patients) or two (2 patients) occluding spring coils. Of these 29 patients, 19 had a clinically apparent and 10 had a silent patent ductus arteriosus. Average ductus minimal internal dimension was 1.7 mm (range 1.0 to 3.0). Complete closure of the ductus was confirmed in 27 patients by aortography or color flow imaging or both (in 24 within 4 h, in 2 after 6 weeks and in 1 after 6 months). Six weeks after implantation, two patients had a tiny residual patent ductus arteriosus noted on color flow imaging. One patient did not have successful implantation. This patient had a 3.2-mm ductus, and two coils migrated to the distal left pulmonary artery and could not be retrieved. There were no deaths or any significant complications noted during early or late follow-up in these patients. CONCLUSIONS: Occluding spring coils may have additional application in closing the small patent ductus arteriosus.

Surgical management of tricuspid atresia and anomalous left brachiocephalic vein.

An anomalous left brachiocephalic vein is an uncommon systemic venous anomaly, which usually has no clinical significance. We describe a case of tricuspid atresia with such an anomalous left brachiocephalic vein. The presence of this unusual venous anomaly had a number of implications in the surgical management of the tricuspid atresia.

Transvaginal sacrospinous colpopexy for vault and marked uterovaginal prolapse.

OBJECTIVE: To assess the results of the sacrospinous colpopexy procedure for the treatment of vault prolapse following hysterectomy and marked uterovaginal prolapse. DESIGN: A prospective study of all patients undergoing sacrospinous colpopexy for vault and marked uterovaginal prolapse between December 1991 and December 1992. SETTING: Kent and Canterbury Hospital, Canterbury. SUBJECTS: Forty women with vault prolapse following hysterectomy and 24 with marked uterovaginal prolapse. INTERVENTIONS: All patients underwent posterior vaginal repair, enterocele sac obliteration and sacrospinous colpopexy. In 48 patients an anterior vaginal repair with suburethral buttressing sutures was also performed. A long-needle bladder neck suspension operation (Raz procedure) was included for three women with coexistent stress incontinence. In 13 patients a vaginal hysterectomy was performed and in 11 the uterus was conserved. A postanal sacrorectopexy was performed on one patient with marked rectal prolapse. RESULTS: The mean follow up period was five months. So far, there have been three failures in the group treated for vault prolapse. One of these underwent a successful repeat sacrospinous colpopexy and repair. The main long term complication was cystocele formation. One sexually active patient complained of dyspareunia following surgery. CONCLUSION: The sacrospinous colpopexy is effective in the treatment of vault prolapse and compares favourably with abdominal vault supporting procedures. It avoids major abdominal surgery and allows the surgeon to correct coexistent cystocele and rectocele. This procedure is also a useful adjuvant when treating marked uterovaginal prolapse.

Vaginal vault prolapse.

Vaginal vault prolapse is a difficult and challenging condition to treat. Standard vaginal repair operations often fail to support the prolapsed vault adequately. Transvaginal sacrospinous colpopexy is an effective procedure with many advantages over abdominal operations.

GnRH analogue in assessing chronic pelvic pain in women with residual ovaries.

OBJECTIVE: To assess whether suppression of ovarian function by a gonadotrophin releasing hormone (GnRH) analogue could assist in the diagnosis of chronic pelvic pain in women with residual ovaries. DESIGN: Uncontrolled, observational study. SETTING: District general hospital (seven women) and teaching hospital (one woman). SETTING: Eight women with residual ovaries and chronic pelvic pain. INTERVENTIONS: Goserelin 3.6 mg every 28 days was used followed by surgery to remove residual ovaries. MAIN OUTCOME MEASURES: The women's response to goserelin and surgery (12 months or more post-operatively) was assessed clinically. RESULTS. Goserelin was associated with resolution of pelvic pain in the six women who obtained relief of pain with oophorectomy. The only woman who did not respond to goserelin also failed to gain relief with surgery. One woman who responded to goserelin declined surgery. CONCLUSIONS: Suppression of ovarian function by GnRH analogues may allow differentiation of pelvic pain caused by the residual ovary syndrome from other causes. This would enable selection of cases likely to benefit from surgery, avoiding potentially difficult surgery in women who will gain little or no relief of symptoms with surgery. Only eight cases are reported and a randomised controlled trial would be required to determine the place of GnRH agonists in the treatment of the residual ovary syndrome.

Transcatheter coil closure of a right pulmonary artery to left atrial fistula in an ill neonate.

Although rare, a congenital direct fistula connection between the proximal right pulmonary artery and the left atrium can present as cyanosis in the newborn. We report the first case in which catheter-based coil closure of such a fistula in a neonate resulted in rapid clinical improvement, obviating the need for surgical repair.

Hemodynamics and coronary blood flow during experimental aortic valvuloplasty: comparison of the dual versus the single catheter methods.

During thoracotomy 12 anesthetized swine were instrumented and valvuloplasty catheters were positioned at the aortic anulus. Thirty-second occlusions of the left ventricular outflow tract were performed with a single catheter (n = 34) and with simultaneous inflation of dual catheters (n = 47). Left anterior descending coronary artery blood flow fell to minimums of 15% of baseline flow (SD 13.9%) during single balloon occlusion and to 63.8% of baseline flow (SD 22.8%) during dual balloon occlusion. Main pulmonary artery flow fell to minimums of 13.6% of baseline flow (SD 17.3%) during single balloon occlusion and to 66.9% of baseline flow (SD 18.3%) during dual balloon occlusion. Femoral artery systolic pressure dropped to 20.1% of baseline pressure (SD 5.6%) during single balloon occlusion and to 82.6% of baseline pressure (SD 8.1%) during dual balloon occlusion. During single balloon occlusion, 8.5 (SD 3.5) premature ventricular contractions were observed and 2.8 (SD 1.6) premature ventricular contractions occurred during dual balloon occlusion. After deflation of the valvuloplasty catheters, the time to return of baseline flow in the left anterior descending coronary artery was 28.4 second (SD 23.2 seconds) with the single balloon method and 4.8 seconds (SD 3.7 seconds) with the dual balloon method. All of these differences were statistically significant (p less than .001). During occlusion of the left ventricular outflow tract by dual valvuloplasty catheters, there were better hemodynamics, higher coronary blood flows, and fewer premature ventricular contractions than during occlusion by a single catheter. After occlusion by dual catheters, returns to baseline coronary flows were more rapid than after single catheter occlusions. These data may have application to clinical aortic valvuloplasty.

Spring coil embolization of a patent ductus arteriosus in an adult.

To date, coil embolization has been reserved for occlusion of the small patent ductus arteriosus (PDA) because of potential dislodgement of the coils. We report a case of a larger, hemodynamically significant PDA in an adult which was successfully closed by two spring coils using a "crossed catheter" technique for coil delivery.

Prograde double balloon dilation of congenital aortic valve stenosis: a case report.

A new method for prograde balloon dilation of severe congenital aortic valve stenosis is described. Two TEGwire balloons were used prograde through bilateral femoral venous sheaths. Excellent hemodynamic results were achieved, without the need for retrograde left heart catheterization and femoral arterial sheath placement.

Uterine preservation or hysterectomy at sacrospinous colpopexy for uterovaginal prolapse?

This study retrospectively compared 34 women who had a sacrospinous hysteropexy and 36 who had a vaginal hysterectomy and sacrospinous fixation for symptomatic uterine prolapse. All women underwent independent review and examination, with a mean follow-up of 36 months in the hysterectomy group and 26 months in the hysteropexy group. The subjective success rate was 86% in the hysterectomy group and 78% in the hysteropexy group (P = 0.70). The objective success rate was 72% and 74%, respectively (P = 1.00). The patient-determined satisfaction rate was 86% in the hysterectomy group and 85% in the hysteropexy group (P = 1.00). The operating time in the hysterectomy group was 91 minutes, compared to 59 minutes in the hysteropexy group (P < 0.01). The mean intraoperative blood loss in the hysterectomy group was 402 ml, compared to 198 ml in the hysteropexy group (P < 0.01). The sacrospinous hysteropexy is effective in the treatment of uterine prolapse. Vaginal hysterectomy may not be necessary in the surgical treatment of uterine prolapse.

A case of congenitally protected d-transposition of the great arteries in a very low-birth-weight infant.

An arterial switch is the corrective procedure of choice for d-transposition of the great arteries but may be associated with increased morbidity and mortality when performed in low-birth-weight infants. Conversely, delaying surgery often leads to left ventricular "deconditioning" as pulmonary arteriolar resistance decreases. We present an infant with a birth weight of 940 g with d-transposition of the great arteries with an intact ventricular septum whose bilateral pulmonary artery branch stenosis allowed for maintenance of near systemic left ventricular pressure, thereby protecting against deconditioning. This case also represents the smallest reported patient to undergo a successful balloon atrial septostomy.

Implantation and intermediate-term follow-up of stents in congenital heart disease.

BACKGROUND: Balloon-expandable stents (Johnson and Johnson Interventional Systems) have been in use for congenital heart disease since late 1989. They have made possible treatment in previously untreatable branch pulmonary artery stenoses and systemic venous stenosis. The purpose of this report is to detail the results and intermediate-term follow-up of stents used for treatment of congenital heart disease. METHODS AND RESULTS: Eighty-five patients underwent placement of 121 stents in Houston and Boston. Fifty-eight patients had stents put in pulmonary arteries, nine had stents in conduits or outflow tracts, and 21 had stents in venous stenoses or narrowed Fontan anastomoses. (Three patients had stents in two locations.) These stent procedures resulted in gradient reduction from 55.2 +/- 33.3 to 14.2 +/- 13.5 mm Hg in pulmonary arteries, from 41.4 +/- 26.0 to 20.7 +/- 17.0 mm Hg in conduits or outflow tracts, and from 9.8 +/- 6.9 to 2.4 +/- 3.1 mm Hg in venous stenoses or Fontan anastomoses. Diameter of narrowings increased from 4.6 +/- 2.3 to 11.3 +/- 3.2 mm in the pulmonary artery, from 8.8 +/- 3.6 to 12.7 +/- 2.6 in conduits, and from 3.8 +/- 2.9 to 11.3 +/- 2.8 in venous stenoses. Follow-up has shown stent fracture in one patient, restenosis in one, and sudden death in one. Recatheterization has been done in 38 patients an average of 8.6 months after stent installation. Compared with immediately postimplant data, there was no significant change in luminal diameter or pressure gradient. Redilation was performed in 14 patients (17 stents) 1 week to 24 months after implantation (mean, 10.2 months), with a small but significant increase in stenosis diameter. CONCLUSIONS: We conclude that stent treatment of vascular stenoses in congenital heart disease retains efficacy at medium-term follow-up and offers a much-improved outlook for patients with these lesions.

New Gianturco-Grifka vascular occlusion device. Initial studies in a canine model.

BACKGROUND: Transcatheter closure of cardiovascular defects remains a challenge. Several occlusion devices are available, but each device has limitations. The purpose of this study was to evaluate the new Gianturco-Grifka vascular occlusion device (GGVOD) in a canine model. METHODS AND RESULTS: A total of 26 GGVODs were implanted as part of short- and long-term studies. In the short-term study, 1 GGVOD was implanted in each of 11 systemic arteries from 3.2 to 9.0 mm in diameter. All 11 arteries were occluded immediately. In the long-term study, an aortopulmonary shunt was placed in 10 dogs (9, Gore-tex graft; 1, subclavian artery) followed by GGVOD implantation; additionally, a GGVOD was implanted in 5 subclavian arteries. The dogs were boarded for 3 to 6 months, then recatheterized and euthanatized. Immediately after implantation, the 5 subclavian arteries and 9 Gore-tex shunts were occluded completely; the 1 subclavian artery shunt had a small residual leak. At recatheterization, all 10 shunts and 5 subclavian arteries were occluded completely. Necropsy revealed all shunts to be occluded, with the aortic and pulmonic orifices covered with a neointimal layer. The mean fluoroscopic time needed for GGVOD implantation was 9 minutes (range, 3 to 22 minutes). CONCLUSIONS: (1) In a canine model, the GGVOD is effective for transcatheter occlusion of arteries and aortopulmonary shunts from 3 to 9 mm in diameter. Possible indications in children include aortopulmonary collateral vessels, long patent ductus arteriosus, systemic-pulmonary shunts, AV malformations, and arteries supplying tumors. (2) GGVOD implantation requires a short fluoroscopic time.