Mark H Glasser
23
• who is known or suspected of having endometrial car- cinoma or premalignant change of the endometrium, such as atypical adenomatous hyperplasia
• who has active pelvic inflammatory disease or pyosalpinx
• who has hydrosalpinx
• who has an intrauterine device in place
• who has active genital or urinary tract infection at the time of treatment.
All patients with menorrhagia should be offered a trial of hormones before being scheduled for endometrial abla- tion. The fear that this would not occur, given the ease of use of the second-generation ablation devices, is largely unfounded. In a study from Glasgow, Scotland, UK, where published guidelines for the management of men- orrhagia exist, the majority (86%) of women undergoing a second-generation endometrial ablation technique received at least one effective medical therapy before sur- gical intervention, indicating a high level of compliance with published guidelines. 6 We favor oral contraceptives, given either continuously or cyclically. An alternative is oral or intramuscular progestins. Norethindrone acetate (Aygestin; Duramed Pharmaceuticals, Pomona, NY) is a very effective treatment for abnormal uterine bleeding when given in a dose of 10 mg/day for 21 days initially and then 5 mg/day on days 15–25 of each cycle. Depot medroxyprogesterone acetate (DPMA, Depo-Provera;
Pharmacia & Upjohn, Kalamazoo, MI) can also be used.
If the patient continues to bleed after 1–2 weeks on the initial course of norethindrone acetate or after the second month of oral contraceptives or DMPA, she is scheduled for an office diagnostic hysteroscopy and endometrial biopsy. These patients will often have polyps or small submucous myomas. All patients with known myomas should undergo diagnostic hysteroscopy to assess whether or not they are candidates for HTA. If the tubal ostea can be seen and the physician determines that fluid can circu- late around the myoma, HTA can be done. Patients with submucous myomas were not included in the phase III FDA (Food and Drug Administration) trials, so the use of the device for this indication must be considered ‘off label’. The use of HTA in patients with submucous myo- mas is discussed later in the chapter.
Pretreatment:
In our early experience, most patients were pretreated with a gonadotropin-releasing hormone (GnRh) agonist using a single injection of Lupron Depot (leuprolide acetate) 3.75 mg (TAP Pharmaceuticals, Deerfield, IL) given in the late luteal phase, and the procedure per- formed 4–6 weeks following the injection. This was according to the protocol submitted to the FDA for the phase III clinical trials of the HTA system. Alternative med- ical pretreatments are danazol 600 mg/day for 3–4 weeks, starting day 1 of the cycle, continuous oral contraceptives (OCs), or norethindrone acetate 10 mg/day for 4 weeks.
Figure 23.1 The HTA control unit with a 3 L bag of normal saline hanging from the integrated IV pole.
Figure 23.2 The HTA sheath with tubing connected and hysteroscope in the sheath. Note the ratcheted tenaculum stabilizer at the top of the sheath.
In a search of the Cochrane database by the Menstrual Disorders and Subfertility Group in Auckland, New Zealand in 2002, the authors concluded that:
Endometrial thinning prior to hysteroscopic sur- gery in the early proliferative phase of the menstrual cycle for menorrhagia improves both the operating conditions for the surgeon and short term post- operative outcome. Gonadotrophin-releasing hor- mone analogues produce slightly more consistent endometrial thinning than danazol, though both agents produce satisfactory results. The effect of these agents on longer term post-operative outcomes such as amenorrhoea and the need for further surgical intervention reduces with time. 7 In the last 2 years we have attempted to schedule the patients in the early proliferative phase of the cycle, with no difference in outcome. In a series of 89 patients pre- sented at the World Congress of Gynecologic Endoscopy in 2004, William Crowder found no significant difference in patient satisfaction (87%, 90.3%, 92.9%) 15 months following HTA in the groups treated with leuprolide depot, continuous OCs, or cycle timing. 8 If excessive endometrium or clots are noted during the diagnostic phase of the HTA procedure, they can be removed with a light suction curettage using the Milex Handy-Vac (Cooper Surgical, Trumbull, CT) with a 7 mm rigid vacurette.
HTA PROCEDURE
The set up of the HTA unit is very simple, as each step is prompted by instructions displayed on the LED monitor.
All of the necessary components are shipped in a sterile
‘peel pack’ container and the tubing connections are col- or-coded. When the power is turned on, the unit goes through a brief self-diagnostic phase. The medical assis- tant is then prompted to connect the disposable heater canister, reservoir, and drain bag in their proper recepta- cles. A 3 L bag of normal saline is then hung from the system’s integrated IV pole and the in-line cassette con- taining the recirculating pump is connected to the unit and locked into place. The disposable sheath (see Fig- ure 23.2) is packed separately and connected to the inflow and outflow tubing by the physician just prior to begin- ning the procedure. Not only are the connections color- coded but also they are male and female, so they cannot be connected incorrectly. Room temperature saline then purges air from the system. This step also checks all com- ponents for leakage and fills the heater canister and fluid measurement reservoir. The fluid is then heated to body temperature to check the fluid heating rod and thermo- couples that monitor fluid temperature.
After the cervix is dilated to 8 mm to accept the insulated 7.8 mm outer diameter hysteroscopic sheath, containing a standard 3 mm or smaller hysteroscope, flow of room temperature saline is started to allow visualization of the cervical canal and the uterine cavity. It is most important not to overdilate the cervix, which should not be dilated beyond 8 mm (24 Fr). The junction of the HTA sheath with the external cervical os should be carefully observed during the flushing stage to confirm a good seal and no fluid leakage. Visualization of both tubal ostea confirms correct intracavitary placement of the device. The micro- processor-controlled system monitors the fluid volume by a series of sensors and automatically stops the flow of saline when a 10 ml deficit is detected. It is not recommended that one does sharp curettage prior to the procedure, since this may open sinuses and lead to intra- vasation of saline. Although this is not dangerous, the machine will automatically stop and a fluid loss alarm will sound. Also, tissue debris created during sharp curettage may clog the outflow of the sheath, causing a fluid excess alarm. Fluid monitoring begins during the heating phase, which starts at room temperature. If a fluid loss alarm sounds, the deficit is displayed on the LED screen at the front of the control unit as well as the rate of fluid loss. This safety feature allows the surgeon to immediately suspect a perforation if the rate of fluid loss is high (>20 ml/min). The HTA system will not function in the event of uterine perforation and it cannot be overridden, since it will again shut off when another 10 ml deficit is detected. Since the procedure is performed under direct hysteroscopic guidance, uterine perforation, false passage, and intrauterine pathology can be detected immediately by the surgeon. It is always possible to create a false passage or a perforation while passing dilators through the cervix. Direct visual introduction should eliminate the possibility of creating a false passage or a perforation while introducing the HTA sheath, unlike blindly intro- duced probes. The flushing cycle is preset for 2 minutes.
Additional 1 minute flushing cycles can be obtained if needed by pressing ‘Start’ once the message, ‘Reached Recommended Flushing Time, Press Start for Additional Time’ appears. After flushing has been completed, a minimum of 1.5 L of saline must remain available.
As saline is heated in the heater canister, the tempera- ture is displayed on the panel. Saline moves through the closed looped system at 300 ml/min, maintaining thera- peutic temperature in the tubing system and uterine cav- ity. Earlier testing established less than a 2°C difference in temperature between saline in the heater canister and the input port on the sheath, so a thermocouple is not needed in the uterine cavity. It takes approximately 3 minutes to heat the fluid to ablating temperature. Once the tempera- ture reaches 80°C, the timer on the microprocessor begins,
the sheath is deviated horizontally or vertically, it is likely to come into contact with the uterine wall, resulting in contractions. Not only is this uncomfortable for the patient, but also it may cause difficulty distending the uterus, which may result in some areas not being com- pletely ablated. At any time, the procedure may be inter- rupted by pressing ‘Stop’, and terminated by pressing
‘Stop’ a second time. To continue after interrupting the procedure, press ‘Start’. The timer will resume and con- tinue until completion of the ablation cycle. Following the 10-minute ablation cycle, a 1-minute cool-down cycle begins. During this cycle the sheath can be moved about in the cavity to assure complete ablation effect.
The fluid in the uterus and tubing is hot, so the sheath must not be removed until the cooling cycle is complete and the machine prompts the physician to remove the sheath. If areas of unablated native endometrium are noted (as would occur if there was poor distention or a fibroid opposing the sidewall shrinks to reveal it), the machine can be shut off and restarted for additional abla- tion time (off-label indication). If visualization is com- promised or if the patient is uncomfortable during the HTA procedure, the cycle can be interrupted by pressing the ‘stop’ button twice, the sheath removed after cool- down, and the machine restarted to complete the cycle after the scope is cleaned or the patient given additional analgesia. To complete the ablation, use the following
‘hot restart technique’.
Hot restart technique
• Press ‘Stop’ twice to abort procedure and allow cool- ing to take place – note ablation time.
• Remove sheath from patient, clean lens and back flush with syringe – administer additional anesthetic if necessary.
• Turn off the power to the unit and turn back on after 5 seconds.
• Repeatedly press ‘Start’ as machine goes through ini- tial start-up instructions.
• During filling phase, press ‘Start’ when fluid reaches 80 ml mark.
• When ‘Insert sheath’ message appears, press ‘Start’
and make sure there is good flow before reinserting sheath.
• Make sure there is enough saline in supply bag and enough capacity in outflow bag. If the collection bag is full, drain the bag and reconnect tubing.
• Ablate for remaining time or for reablation, until the unablated endometrium blanches completely.
even though the temperature of the saline continues to climb for approximately 1 minute until it reaches 90°C.
The ablation cycle lasts for 10 minutes. The optimum time and temperature were determined from earlier studies. 9 During the ablation cycle, blanching of the endometrium is noted on the video monitor. This is fascinating to the patient observing the screen during an office procedure under local anesthesia and provides ‘video analgesia’ as well as reassuring the physician and patient that the abla- tion is occurring normally (Figure 23.3). The junction of the HTA sheath with the external cervical os should be carefully observed during the heating period to confirm a good seal and no fluid leakage.
It is most important for the physician to maintain a steady, central position within the uterus during the ablation cycle and not radically deviate the sheath. Lat- eral movement of the sheath can result in stretching of the internal os, which makes leakage possible. Also, when
A
B
Figure 23.3 Pre- (A) and post-HTA(B) uterine cavity in a 41-year-old woman with severe menorrhagia. Note the large vessels at the fundus completely obliterated post treatment.
hysteroscopists. 11 This is true despite studies in the litera- ture which show patients having hysteroscopy in an out- patient setting compared to those done in a day case setting (surgicenter) have a more rapid return to normal activities and require no greater amount of postoperative analgesia. 12 There are also economic benefits to patients, their employers, and to the healthcare system by perform- ing hysteroscopy in the outpatient setting rather than in a day case setting. 13 The outpatient group in this study from the UK required significantly less time off work compared with the day case group, resulting in the aver- age loss of income being twice as much in the day case group. Travel costs incurred by the women were 74% more in the day case group compared with the outpatient group.
Day case hysteroscopy costs to the British National Health Service were significantly more per patient than perform- ing an outpatient hysteroscopy.
There are several other benefits to the patient of hav- ing a surgical procedure performed in the office rather than in the operating room (OR). In addition to elimi- nating the risk of general anesthesia, having the procedure performed in the familiar surroundings of the gynecolo- gist’s office is far less intimidating than the OR, thus reducing anxiety. Also, the ability to have a support per- son in the room and to converse with the physician fur- ther reduces anxiety and the discomfort which, conversely, is magnified by anxiety.
There are many physician benefits of office-based surgery as well, such as avoiding the hassle of scheduling, dicta- tion, and ‘down time’ in the OR caused by cases running overtime or being ‘bumped’ from the schedule. Time commuting to the hospital is better spent increasing office productivity and accessibility.
There are many barriers to performing procedures in the physician's office, including equipment costs and maintenance, rapid obsolescence of technologies, lack of procedure room space, staffing and staff training, and anesthesia requirements. Traditionally, office procedures were reimbursed at rates equal to or lower than those rates for procedures performed in a hospital or surgicenter, which made it economically disadvantageous for the phy- sician to perform procedures with high disposable kit costs in the office. Fortunately, this is changing in the USA, with the publication of the 2006 National Physician Fee Schedule Relative Value Guide. Hysteroscopic endome- trial ablation (resection, electrosurgical ablation, ther- moablation – CPT 58563) performed in the office is now reimbursed at 63.09 RVU (relative value units) compared to 9.65 RVU for the same procedure performed in a facil- ity. Similarly, thermal endometrial ablation without hys- teroscopic guidance (CPT 58353) is now reimbursed at 39.63 RVU for the procedure performed in the office compared to 6.02 RVU for the same procedure performed Cervical control
A tight cervical seal is necessary to prevent leakage of fluid from the cervix into the vagina. The use of laminaria tents and misoprostol should be avoided, since both of these agents can soften the cervix, making it difficult to main- tain a tight seal. I prefer to dilate the cervix using Hegar dilators, which are non-tapered. The use of Pratt or Hanks dilators will result in the mid cervix and external os being dilated to 9 mm and 10 mm, respectively, if the internal os is dilated to the requisite 8 mm. The use of a Gimple- son four-pronged tenaculum will often help maintain the cervical seal in a multiparous patient with a wide patulous cervix. 10 Another simple technique to employ for the patulous cervix is to grasp the cervix laterally with one tenaculum held vertically and compressing the anterior to the posterior lip; inserting the sheath to its proper posi- tion and then applying a second tenaculum to compress the anterior and posterior lips of the cervix on the oppo- site side of the sheath creates a tight cervical seal. If either of these methods is unsuccessful, the use of an endoscopic loop cinched tightly around the cervix after the sheath is inserted into the cavity is often effective. As a last resort, a McDonald circlage suture can be placed in the cervix and tied following insertion of the sheath to its proper intracavitary position beyond the internal os.
The integrated tenaculum stabilizer at the top of the sheath (see Figure 23.2) prevents inadvertent removal of the device from the cervix during the procedure while heated saline is being circulated. The physician must actively release this ratcheted holder before the device can be removed. The next-generation HTA sheath, which is awaiting FDA approval, will have a cervical sealing device built into the sheath, which will eliminate any possibility of transcervical leakage. In the author’s personal experi- ence of 286 HTAs, there has not been any instance of saline leakage resulting in cervical or vaginal burn.
OFFICE ABLATION UNDER LOCAL ANESTHESIA USING THE HTA SYSTEM While minimally invasive gynecologic surgery has dra- matically decreased hospitalization and shortened disabil- ity for countless numbers of women over the last two decades, many gynecologists have been reluctant to move some of these procedures out of the formal operating rooms of hospitals and ambulatory surgical centers to their offices. In an informal survey at four recent ‘hands on’ postgraduate hysteroscopy courses sponsored by the American College of Obstetricians and Gynecologists (ACOG), only 5–10% of participants did any office hys- teroscopy, while approximately 70% were experienced
The HTA system, because it operates at low pressure (50 mmHg) and works by circulating free-flowing saline in the uterine cavity at 90°C without any instruments touching the uterine wall, is ideally suited for office use under local anesthesia. In a study of 40 patients to assess and establish the feasibility of outpatient global endome- trial ablation using the HTA device with local cervical block and oral non-steroidal anti-inflammatory drugs (NSAIDs), Farrugia and Hussain concluded that, since the HTA system operates at a low intrauterine pressure, and no manipulation of the device is required during the ablation cycle, it is ideal for performing endometrial abla- tion in an outpatient clinic. This initial study shows the feasibility and patient acceptability of this procedure under local anesthesia. 17
There are numerous protocols for administering par- acervical/intracervical blocks described in the literature for office procedures. Several are outlined in a review article by Leclair. 18 At the Kaiser Permanente Medical Center in San Rafael, California, we have performed over 12 000 gynecologic office procedures under local anesthe- sia with minimal oral sedation over a 25-year period.
These procedures included pregnancy termination, both elective and for missed and incomplete abortions, diag- nostic hysteroscopies, hysteroscopic sterilizations, and, to date, 286 HTAs.
Protocol for office anesthesia
All procedures were done in the medical office treatment room under local anesthesia after oral premedication at home and intramuscular (IM) premedication in the office.
Our oral premedication regimen consists of 800 mg of ibuprofen (Motrin; Pharmacia & Upjohn, Kalamazoo, MI), 10 mg of diazepam (Valium; Roche, Nutley, NJ) and two hydrocodone/acetominophen (Vicodin; Abbott, North Chicago, IL) tablets taken at home 1–2 hours prior to the procedure. The patients are instructed to arrive 30 minutes prior to their scheduled appointment and are given an IM injection of ketorolac (Toradol; Roche, Nutley, NJ) 30 mg and atropine 0.4 mg at that time.
Toradol has peripheral effect as well as being a prostaglan- din synthetase inhibitor and is very effective for office endometrial ablation. Atropine is used to prevent vasova- gal reactions. A paracervical/intracervical block with 1%
mepivacaine (Polocaine; AstraZeneca, Wilmington, DE) using a 10 ml control-top syringe and a 22 gauge spinal needle is then administered. We chose mepivacaine since it is relatively safe (75% protein bound) and is longer act- ing than lidocaine. First, 2 ml is given in the anterior lip of the cervix before it is grasped with a single-toothed tenaculum. The needle is placed against the cervix and the patient is instructed to cough, which results in ‘self-injection’.
in a facility. The office RVU for hysteroscopic steriliza- tion (CPT 58565) is 57.77 compared to the facility RVU of 12.11. 14 Insurance companies are slowly adopting these rates, making it economically advantageous to perform procedures in the office setting, especially diagnostic hys- teroscopy, hysteroscopic endometrial ablation, and hyst- eroscopic sterilization. Phillip Brooks MD , one of the pioneers of hysteroscopy said:
If possible, the ideal role for the new ‘simple’ or
‘global’ ablation should be for office or treatment room use thereby avoiding the use and risks of general or regional anesthesia. 15
The control of pain seems to be the greatest concern of physicians attempting to perform hysteroscopic proce- dures in the office setting. The early experience in setting up an ambulatory hysteroscopy service at a large endos- copy unit in Australia provoked a review of the literature, due to an unacceptably high failure rate. The review was undertaken to establish the accepted success rates and reasons for failure, and to assess evidence for various anal- gesic protocols through randomized controlled trials.
Twenty-nine separate studies were reviewed, which included 10 232 patients. The success rate varied between 69% and 100%, with most studies citing a 90–100% suc- cess rate. Failures were due predominantly to pain (29.4%), stenosis (28.2%), and poor view (20.8%). The authors concluded that most failures were probably due to inadequate analgesia. 16
The sensory innervation of the uterus derives both from the sympathetic and parasympathetic nervous sys- tems. Pain in the first stage of labor stems largely from the uterus. Sensory fibers to the cervix accompany the para- sympathetic fibers arising from the S2-S4 region of the spinal cord to the pelvic plexus and travel through Fran- kenhauser's ganglion to innervate the cervix and myome- trium. Pain in the cervix is referred to the sacral region.
The uterus is also innervated by sympathetic fibers arising from the lower thoracic and upper lumbar regions of the spinal cord (T12-L2), which follow the same pathway.
The paracervical block (PCB), sometimes called a utero- sacral block, places the local anesthetic at the base of the broad ligament and lateral walls of the lower uterine seg- ment, blocking the afferent pathways which lead to Fran- kenhauser's ganglion. For many years this was a very popular anesthetic for the first and second stages of labor.
With the advent of fetal monitoring, deep decelerations in fetal heart rate were noted after administration of the block, and thus PCB fell into disfavor for obstetrical anal- gesia. However, its use for gynecologic procedures is based on sound physiologic principles.
The cervix and uterus are sensitive to stretch but insensitive to heat.