Virtual hysterosalpingograghy to evaluate the uterus and tubes patency

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPPONI, A

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

Hysterosalpingography is the current outpatient diagnostic study routinely used to assess tubal patency and uterine cavity in patients with reproductive disorders. The study identifies tubal blockages, images compatible with salpingitis, peritubal adhesions, submucosal fibroids, endometrial polyps, uterine adhesions, adenomyosis and numerous uterine malformations. It has a sensitivity and specificity of around 90-100% for uterine cavity pathologies and around 75-100% in tubal pathology. However, it is important to note that it causes discomfort in a high percentage of patients. There is now a virtual hysterosalpingography (VHSG) with the potential advantage of obtaining images similar to those obtained by the conventional hysterosalpingography, along with the reconstruction of new images (with a better characterisation of the various anomalies, especially endoluminal lesions), as well as the duration of the study being shorter (since it only requires the single instillation of a contrast medium), less need to mobilize the patient and no need for the discomfort of cervical traction. This report is conducted to assess the diagnostic utility of this technology in identifying uterine and tubal abnormalities. Technology The VHSG is a technology based on the classic radiological study of conventional hysterosalpingography, but carried out by multidetector computed tomography instead of x-rays. As with the current tomography of 64 detector rows, the cuts are 0.9 mm thick. The images are processed and axial images are obtained, multiplanar images are reconstructed, projections of maximum intensity are obtained, volume assessment is conducted, and it becomes a virtual endoscopy. It is an outpatient diagnostic procedure, minimally invasive and requiring no sedation of anaesthetic. It is important to note that it is not necessary to make any traction on the cervix, preventing the use of forceps or other devices that are usually used in the conventional method. Objective Evaluate the available evidence on the usefulness, efficacy, safety, cost-effectiveness and policy issues relating to insuring the use of virtual hysterosalpingography in patients with infertility. Methods A search was conducted in the major bibliographic databases MEDLINE, DARE, NHS EED generic Internet search engine, rating agencies and health funders. Priority was given to the inclusion of systematic reviews (RS), randomized controlled trials (RCTs), health technology and economic assessments, guidelines for clinical practice and insurance policies of other health systems. Results Two cross-sectional studies and two case series were found, all published by the same group of researchers. In 2008, a cross-sectional study evaluated 60 patients diagnosed with infertility. In 30 women, HSG was performed first and then VHSG, and then in reverse order in the other 30. Studying the cervix with erina forceps was performed in all patients with HSG and in 25 patients with VHSG, while with the remaining 35 patients forceps were not used. The duration of HSG was 28 +/- 3 minutes in the conventional HSG and 5 +/- 3 minutes in the VHSG. A case with two small polyps, one case of uternine synechiae and two cases with patent tubes were observed only with VHSG. Using the conventional VHSG as the gold standard, a sensitivity and specificity of 100% and 92% are used respectively for uterine cavity (up to 100% with the 64-row scanner) and 80% in both features for tubal disease (amounting to 100% in 64 rows). In the scale used (1 to 4), the HSG discomfort had a mean of 3, while the VHSG group without the use of erina forceps was 1.4 (p<0.05). Another cross-sectional study published in 2008 evaluated 22 patients diagnosed with infertility. All patients underwent a same-day conventional HSG and VHSG. The VHSG had an adequate sensitivity and specificity. In 2009, a series of 209 patients with primary or secondary infertility who had a VHSG were evaluated. In 116 cases (55%) patients reported no discomfort, 54 noted light discomforts (25.8%), in 33 cases it was moderate (15.8%) and in 6 cases it was severe (2.9%). In 2009, an evaluation was published of another series of 1000 women with VHSG. There were no complications during the procedure. The average length of the procedure was 3 +/- 1 second. The average effective radiation dose per patient was 2.58 +/- 0.75 mSv. The costs of the VHSG are between $1200 and $ 2400 (Argentinean pesos July/2011), as a health organization agent or for an individual, the conventional HSG between $180 and $800 respectively. Conclusions The main advantage of the VHSG is that it is better tolerated, being less invasive than the conventional HSG. The VHSG also showed good operating results for sensitivity, specificity and tolerance to the procedure, although these results come from few clinical studies conducted by the same research group designs and with relatively weak designs for evaluating the usefulness of VHSG and for drawing conclusions on how this technique compares with the usual practice of HSG. A major difficulty in evaluating this technology is that there is no clear evidence on what clinical utility the discovery of many of the abnormalities detected by the VHSG could have. While it is possible to conclude that VHSG would have similar or better diagnostic parameter than the conventional HSG, the findings cannot be checked with the infertility clinic meaning it will be difficult to conclude what the potential benefits of this new technology are, given that the greater sensitivity of the VHSG could also increase the number of false positive interventions and potentially increase the interventions and costs. Since studies which evaluate the impact of different lesions and their size in the reproductive prognosis are not published, and given that the VHSG is much more expensive than conventional HSG, it is difficult to assess this new technology, meaning we cannot conclude, at present, if in the future it could replace the conventional hysterosalpingography