Transvaginal US - HD

Welcome and Introduction

Welcome to the Omnia Education Online activity entitled a Stenographer's Guide to the Use of Transvaginal Ultrasonography for confirming permanent contraception in insert placement presented by Laura Decker, B-S-R-D-M-S-M-H-A.

Prior to beginning the activity, please be sure to review the faculty and commercial support disclosure statements as well as the learning objectives.

Learning Objectives

During this presentation, I'm going to identify patients who are appropriate candidates for transvaginal ultrasound to confirm proper micro insert placement, understand the benefits and disadvantages of TVU in the confirmation process for micro insert placement, and enhance sonographer awareness of the training certification program for the confirmation of appropriate TVU insert placement as requested by the FDA of the device manufacturer.

Presenter Introduction

Hi, I'm Laura Decker from Evansville, Indiana. I am the sonographer for Dr. Cindy Budzinski and Rupal Duran to dedicated board certified gynecologist.

Background on Female Sterilization

Traditionally, female sterilization was only offered in the operating room under general anesthesia. The risk of any surgery in the abdomen include injury to underlying intestines or blood vessels as well as the risk and recovery of general anesthesia.

Fortunately, there is now a new method to permanent contraception, which is the permanent birth control inserts. The placement of these inserts can be performed in the physician's office via hysteroscope.

A recent study reported that patients preferred hysteroscopic laparoscopic sterilization procedures because of the opportunity for an in-office procedure with local anesthesia and a faster return to routine activity. In fact, we perform hundreds if not thousands of permanent sterilization procedures right in our office.

Confirmation Test Requirements

A confirmation test must be given and done three months following the micro insert procedure to confirm that the devices are properly placed and the woman can rely on the micro inserts for birth control.

In July, 2015, the US Food and Drug Administration approved the use of transvaginal ultrasound as an alternative confirmation test for these micro inserts. Up until the FDA approval of TVU a modified HSG was required to confirm appropriate placement.

I'm gonna give some examples of cases that are pretty common in our practice that may reflect permanent birth control inserts. Ultrasound confirmation test.

Appropriate Candidates for TVU Confirmation

As long as a patient falls in the category as an appropriate candidate for transvaginal ultrasound confirmation test, an ultrasound will be done at three months post-placement.

In order for a patient to qualify for TVU confirmation, there is certain criteria that must be met during the actual placement of the PBC inserts. The criteria includes one to eight trailing coils on each side. Procedure and placement of PBC inserts must be done in less than 15 minutes and the procedure must be done with no complications.

Ultimately, the performing physician will determine whether or not the patient qualifies for TVU confirmation. Even if the patient does qualify for TVU confirmation, they still have the option to opt for an HSG as it does provide definitive results.

Pros and Cons of TVU Confirmation

Just like anything, there are pros and cons of the TVU confirmation process. Being able to have your confirmation test done directly in the physician's office makes many patients more comfortable. Majority of the patients like being familiar with their physician's office and the staff. Also being able to have this done right in the comfort of those helps put some patients at ease as far as health factors go.

Using ultrasound also steers clear of radiation and avoids exposing the patient to radiation. An ultrasound is also significantly cheaper than an HSG, which can be a huge deciding factor for many patients.

A modified HSG is definitive and unfortunately an ultrasound is not. Although as a sonographer, we can tell where the inserts are located and whether or not they are traversing the utero tubal junction. We cannot tell if the fallopian tube is actually occluded.

Approximately 10% of TVU patients may be referred and sent for an HSG based on equivocal ultrasound results. Ultrasound also has barriers that may limit what they are actually able to visualize. We commonly run into barriers of the female pelvis that are inevitable to bypass. These barriers include body habitus of the patient, bowel, gas, and limited visualization of pelvic structures.

Case Studies

Case 1

We'll begin case one. A 23-year-old woman presents to the office for consultation of permanent sterilization. She is engaged to be married and has been pregnant twice with two live births. The physicians have discussed the higher regret with PBC inserts since she is a young patient and also stressed the permanency and reiterated that this is non reversible.

After consultation, the patient is scheduled as soon as possible for PBC insert placement. The day of the procedure, the patient is prepped accordingly and presents to the procedure room. The placement was done with no complications and the actual time of the procedure was four minutes which counts for the time the hysteroscope was inserted. The inserts were placed and the hysteroscope was removed. There were six trailing coils on the left and two on the right. The blood pressure during the procedure was one 15 over 69 and her pain during the procedure was a two out of 10.

Three months after the procedure, the patient presents back to her office for her three month coil check and confirmation test. The transvaginal ultrasound shows the bilateral permanent birth control inserts visualized bilaterally and they appear in optimal position traversing the utero tubal junction. The bilateral coils are visualized as highly echogenic inserts based on patient body habitus and experience scanning skills. The entire length of the insert can be identified as visualized in the image above position of the insert in the cornua and relationship with the endometrium and utero tubal junction should be noted to determine placement. Those are key objects in the ultrasound report to the physician.

At this appointment and after a patient's ultrasound and confirmation test, she is told that she is able to rely on the permanent birth control inserts for sterilization purposes. No HSG is required onto case two.

Case 2

A 42-year-old woman presents to the office for consultation of the placement of permanent birth control inserts. This patient desires permanent sterilization after two pregnancies and two live births. Permanent birth control inserts were discussed and agreed upon at the in-office consultation. This patient had a bilateral tubal ligation then reversal and now desire sterilization again but would like to steer clear of the operating room if possible.

Patient presents to the office and is prepped properly during placement. There is some difficult placing the right micro insert due to prior scarring inside the endometrial cavity from the other procedures that the patient has had performed in the past. The time of the procedure was eight minutes where the scope was inserted. The micro inserts were placed and the hysteroscope was removed. Her blood pressure during the procedure was 1 52 over 84. There were eight trailing coils on the left and 16 on the right. Her pain during the procedure was a three out of 10 due to difficulty of placing the PB inserts and the large number of trailing coils on the right large being greater than eight.

An ultrasound was performed immediately after placement to visualize inserts trailing into the fallopian tube. However, performing an ultrasound immediately after the PBC placement is off-label and should not be performed regularly as the results are not definitive performing an ultrasound immediately after the procedure, specifically after a hysteroscope has been inserted. Visualization of the uterus and endometrium can be difficult due to the trauma of the cavity and the water and air that has been projected into the cavity.

An ultrasound was performed and the right micro insert was visualized adequately, but the left micro insert was not in this transverse image. You are able to see the right micro insert in the correct position but the left insert is not clearly seen, which means that this exam does not confirm proper position. There is also some air in the pelvis from the recent procedure which is obscuring optimal views of the PBC inserts due to limited views of the inserts.

The patient is sent for a flat plate x-ray that showed both PBC inserts and satisfactory position since the patient did not have between one and eight trailing coils bilaterally at the time of the procedure. She does not qualify for the TVU confirmation test, but instead she will be sent for the HSG for confirmation at the three month HSG. She will be told whether or not she can rely on them for birth control reasons. After the HSG is resulted, results and imaging will be sent to the ordering and performing physician.

Next we'll discuss case three.

Case 3

A 3-year-old woman presents to the office desiring permanent sterilization. She has been pregnant three times with two live births. Options are discussed and patient ultimately decides on permanent birth control inserts. Patient presents to the office for the procedure and she goes through the PBC insert procedure with zero complications. The time of the procedure was only three minutes. There were two trailing coils on the left and one on the right. Her blood pressure during the procedure was 1 15 81 and her pain during the procedure was a seven out of 10.

Three months later, she presents to the office for an ablation which is the treatment of heavy periods. Her PBC insert procedure went smoothly and she qualifies for the TVU confirmation and does not require HSG testing. Before an ablation is performed, a confirmation test must be performed to visualize permanent birth control. Inserts and position must be declared. If PVC inserts were not visualized in proper position, ablation would not be performed just yet when the transvaginal ultrasound is performed.

Results demonstrated the left permanent birth control insert in an abnormal position in the image above the insert is visualized parallel to the endometrial stripe when in the sagittal view. Therefore, this signifies a perforation. This is actually pretty obvious when scanning the uterus for visualization of the micro inserts. The segment of the linear axis of the insert appears to be elongated out in an abnormal position. These are key things to look for when performing a confirmation test.

The patient is sent for an HSG or her left coil appeared to be partially in the tube and partially perforated out while the right micro insert was in correct position and both tubes were occluded. Counseling to the patient is done due to abnormal position of the left micro insert. She cannot rely on the devices for contraception and it would be suggested we proceed to a bilateral cell ectomy in the operating room for guaranteed sterilization. This would have ultimately been the alternative regardless if the PBC insert procedure would have been performed or not. Patient verbalizes understanding and she desires to proceed with the bilateral salpingectomy.

Case 4

A 37-year-old woman presents to the office for counseling and consult for permanent sterilization. She has been pregnant five times with five live births which makes her an extremely busy mother. After discussing the options of permanent sterilization, she decides that the permanent birth control inserts done right in the office with no downtime would be the best choice for her so she is able to get back to her busy lifestyle the next day.

She presents to the office a couple of weeks later for the procedure. The procedure is done with zero complications. Her blood pressure during the procedure was 1 29 over 82. She had four trailing coils on the left and four on the right. The total time of the procedure was seven minutes and her pain during the procedure was a one out of 10. The low pain scale is no surprise since we make a reference to on a pain scale of one to the worst labor pains you have ever experienced and she has had five children. Due to the ease of the procedure. She left the office with an appointment for an ultrasound confirmation test in just three months.

Three months later, she visits the office for her transvaginal ultrasound confirmation test. She has had no problems or complaints of her PBC inserts and has resumed her busy lifestyle with her five children. When the ultrasound is performed, both inserts are visualized beautifully. The entire insert is visualized traversing the utero tubal junction and the distal ball tip is even visualized beautifully, which can be unusual in a less than perfect female pelvic anatomy. In the image above, you can see the whole insert trailing from the endometrium out into the utero tubal junction. This is an ideal case for a stenographer like myself and the physician who did the placement. We love to see successful placements, beautiful images, and great results in order to perform the transvaginal ultrasound confirmation test.

Required Skills and Challenges

Basic T use skills are required including the ability to identify normal pelvic anatomy and pelvic structures with sagittal and transverse views of the uterus. Approximately 10% of TVU patients may be referred and sent for HSG based on equivocal results. Regardless, this could be based on whether or not the sonographer is able to obtain the proper imaging barriers of the female pelvis, which include patient body habitus, bowel gas, or limited visualization of pelvis structures or if unsatisfactory classification is suspected.

Ultimately, there are some challenging factors when performing a confirmation test and if there is any doubt, further testing should be ordered and performed to ensure that the patient has the contraceptive that they are wanting.

Summary of Cases

During this presentation, I discussed four different cases, all of which are common for an ultrasonographer to see during A TVU confirmation test. Cases one in four are what we hope to see with every patient that has the PBC insert placement. They are ideal cases with no complications or intervention required.

Case two had minor complications with a large number of trailing coils and difficulty during the placement due to her previous scarring inside the endometrial cavity, so she did not qualify for the TVU confirmation test and was ultimately sent for an HSG three months after case three is the one we luckily see very rarely, although she had no complications and did qualify for the three month TVU confirmation test. Once it was performed, the results showed indication of a perforation in which an HSG did need to be performed. The perforation of the micro insert then resulted in a bilateral tubal ligation in the or.

Resources

There are a number of resources available to sonographers and other healthcare professionals regarding the use of TVU to ensure confirmation of appropriate permanent contraceptive device placement. One such resource is the Essure Instructions for Use Healthcare Professionals Guide. Please find additional information under related content. For this activity.

The US Food and Drug Administration requested that the manufacturer of shore enhance sonographer awareness of the availability of the training certification program provided by the manufacturer. For the confirmation of appropriate TVU insert placement, please find additional information at www.shoremedicalresources.com.

Finally, the American Institute of Ultrasound in Medicine or A IUM is a valuable resource for obtaining information regarding the utilization of TVU. Please visit www.aium.org for more information.

Conclusion

To earn your CME credit, please proceed to take the post-test and evaluation.