Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial

This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.     

Cross-cultural issues in the use of socio-medical indicators.

Socio-medical indicators for the assessment of physical, psychological and social conditions have become increasingly popular as adjuncts to traditional clinical and epidemiological measures. Most such indicators have been developed in the U.S.A. or Great Britain and considerable problems may arise from attempts to use them in other cultures. The ambiguity inherent in the terms "health" and "illness" is compounded cross-culturally by differences in the meaning system of cultures, their values, expectations and historical development. Consideration of cultural differences must precede any attempt to adapt already existing instruments for use in a culture or within a sub-group whose members were not included in the development process. Reliability and validity of socio-medical measures can only be assumed after the closest attention has been paid to the technical, conceptual and linguistic issues which arise from translation. This paper details some of the issues involved together with an account of the practical problems arising from the translation of the Nottingham Health Profile into Arabic and Spanish.     

An Incidentally Discovered Left Atrial Appendage Membrane: Case Report and Literature Review

The left atrial appendage (LAA) is an extension of the left wall of the atrium and its close anatomic relationship to the free wall of the left ventricle gives it anatomic characteristics distinct from the left atrium. To date, only seven cases involving a LAA membrane have been described. A patient with an incidentally discovered, partially obstructive membrane at the orifice of the LAA, causing functional stenosis is presented, and our case is compared to those in the existing literature.The clinical significance of LAA membranes remains unknown. These rare membranes are usually an incidental finding on transesophageal echocardiogram during evaluation of an atrial dysrhythmia. It is not clear if these membranes could be promoting atrial fibrillation or if the association is merely a result of sampling bias. These membranes may also affect cardioembolic risk. Finally, the increasing use of percutaneous catheter-based therapies such as radiofrequency ablation and occlusion of the left atrial appendage, will likely result in the increasingly frequent identification of these membranes, and when present may increase the technical difficulty associated with these catheter-based therapies.     

Spontaneous thrombosis of a residual arteriovenous malformation in eloquent cortex after surgery: case report

OBJECTIVE AND IMPORTANCE: The presence of a residual arteriovenous malformation (AVM) on postoperative angiograms is typically an indication for prompt return to the operating room to complete resection, because of the risk of early hemorrhage. This approach, however, may involve risks of neurological deficits when the residual AVM is in eloquent cortex. We present a case of complete thrombosis of a residual AVM after surgery. This residual AVM tissue was located in eloquent cortex. Complete spontaneous thrombosis of residual AVMs after surgery has only rarely been reported. This phenomenon raises questions regarding the most appropriate management for residual AVMs in eloquent cortex. CLINICAL PRESENTATION: The patient was a 43-year-old, right-handed, male patient with an AVM centered in the left precentral gyrus. The patient presented with medically intractable seizures and progressive right hemiparesis. After AVM resection, angiography revealed a residual AVM with early venous drainage. Angiography performed 1 week later demonstrated a persisting AVM nidus without early venous drainage. Angiography performed 3 months later demonstrated complete thrombosis of the residual AVM. INTERVENTION: The patient has been monitored for more than 1 year, without additional symptoms or therapy. CONCLUSION: We continue to advocate prompt return to the operating room when postoperative angiography reveals a residual AVM with persistent shunting. When the residual AVM is in eloquent cortex and is small, with a single draining vein, however, observation of the patient (with strict blood pressure control) and repeat angiography after 1 week represent an alternative strategy that is supported by this case report. As this case demonstrates, it is possible for small residual AVMs to thrombose. This may avert the need for reoperation for residual AVMs in eloquent cortex, with the potential for neurological deficits.     

Mycophenolic acid concentrations in long-term heart transplant patients: relationship with calcineurin antagonists and acute rejection

BACKGROUND: When used in conjunction with steroids and cyclosporin, mycophenolate mofetil (MMF) has been shown to significantly reduce mortality and incidence of rejection in the first year after heart transplantation. It also appears that in this early post-transplantation period, the monitoring of immunosuppressive therapies may be warranted. The current study was undertaken to determine if such monitoring is still useful more than 1 yr after heart transplantation. METHODS: Twenty-six patients who had survived the first year after orthotopic heart transplantation and had been on MMF therapy for more than 3 months were prospectively followed. At the time of their routine endomyocardial biopsy blood samples were taken to monitor immunosuppressive therapy. Most patients had two samples taken, on average 109 d apart. RESULTS: There were 22 episodes of asymptomatic rejection documented on a total of 48 biopsies. Of these, only two were of ISHLT (International Society for Heart and Lung Transplantation) grade 3A the remainder being of ISHLT grades 1 or 2. There was no relation between immunosuppressive regimen (tacrolimus and MMF or cyclosporin and MMF) and rejection. There was no relation between monitored immunosuppressive levels and rejection. Patients with the combination of MMF and tacrolimus had significantly higher plasma mycophenolic acid levels despite significantly lower daily MMF dose. CONCLUSION: There does not appear to be a benefit in continued monitoring of plasma mycophenolic acid levels beyond the first year of heart transplantation. There were significant differences in plasma mycophenolic acid levels depending on the type of calcineurin inhibitor concomitantly used.