Adolf Gallinat
22
delivery is calculated automatically on the basis of the uterine cavity length (measured during sounding and dilation) and the uterine width (measured by the device).
These two values are keyed into the controller and the exact power level required is automatically calculated for an optimal ablation of the uterine cavity of a given size.
The power delivery, and automatic procedure termina- tion concept, is based on monitoring of specific well- analyzed physical characteristics of the tissue (impedance/
resistance), allowing for a controlled predictable depth of tissue destruction.
The coagulation of the endometrial layer is a low-im- pedance process, owing a high level of liquid, electrolytes, and hormones present in the endometrial tissue. The endometrium (and cell contents) are vaporized during the high-power ablation and evacuated from the uterine cav- ity by continuous suction. As the ablation front advances and reaches the myometrial layer, the tissue can no longer be vaporized (because of its higher density), and therefore is desiccated. When overall tissue impedance (resistance) reaches 50 Ω (which is equivalent to the impedance of the ablated superficial myometrium), the NovaSure system automatically terminates the ablation process. The vac- uum is continuously generated, maintained, and moni- tored within the uterine cavity throughout the endometrial ablation procedure. By this vacuum (suction), an inti- mate apposition between the endometrium and later myometrium is assured. The presence of a constant vac- uum facilitates removal of the contents of the uterine cavity (blood, electrolytes, hormones) as well as vaporiza- tion of by-products (steam) generated during the bipolar electrosurgical ablation process.
The cavity integrity assessment system is an integral part of the NovaSure system. This automatic safety feature was developed and implemented to assist the physician in the timely detection of uterine wall perforation, thus pre- venting energy delivery. It uses a hysteroflatertype tech- nology. 16 Carbon dioxide is insufflated into the uterine cavity (via the porous device) at a safe flow rate and pres- sure. Once the proper intrauterine pressure (50 mmHg) is reached and maintained for 4 seconds, confirming the integrity of the uterine wall, the RF controller proceeds with the ablation process, which lasts 90 seconds on aver- age. Exclusion of perforation takes about 6–8 seconds and does not prolong the entire procedure. A validated picto- rial blood loss assessment chart (PBAC) scoring system described by Higham 17 was used for a precise and objec- tive quantification of menstrual blood loss before and after ablation.
Only premenopausal women with menorrhagia second- ary to DUB that is unresponsive to medical therapy were treated; all patients had completed childbearing at the time of procedure. All patients had their follicle-stimulating hormone (FSH) levels determined before the procedure, to assure their premenopausal status (FSH >40 U/L).
Patients received no hormonal or surgical (i.e.
curettage) endometrial pretreatment. The procedure performance was not timed to a particular menstrual cycle day.
Figure 22.1 NovaSure handset, showing the bipolar gold-plated porous mesh at the tip. On the left, the intrauterine measuring device determines the cornu-to-cornu distance. Connections for RF energy, CO2 insufflation (cavity integrity assessment system), and the suction system are shown.
Figure 22.2 NovaSure controller. The function is demonstrated by LEDs. An automatic power calculation is made according to the geometry (length and width) of the treated cavity.
In November 1998, we started a prospective study, 18 while Bongers started in November 1999. 19 A random- ized, multicenter clinical trial compared with wire loop resection followed by rollerball endometrial ablation was undertaken at nine investigational sites, four in the USA, four in Canada, and one in Mexico. 20
Inclusion and exclusion criteria were the same for all studies. Only premenopausal women (the premenopausal condition was confirmed by FSH determination) after completed family planning were included. The remaining diagnosis evaluation of the patients was similar to that which is standard for women deemed to be candidates for endometrial ablation: i.e. exclusion of endometrial malig- nancies as well as premalignant histologies. Patients were excluded if they had bacteremia, sepsis, or some other active systemic infection, or active or recurrent chronic pelvic inflammatory disease. Furthermore, coagulopathies or a history of uterine surgery that would have interrupted the integrity of the uterine wall (classic cesarian section, myomectomy) meant exclusion. Women who had previ- ously undergone endometrial ablation were also excluded.
Also, patients were excluded if they had an abnormal Papanicolaou smear, were taking anticoagulants, or were taking drugs that could thin myometrial muscle, such as long-term steroids. Patients with abnormal or obstructed uterine cavity (submucous myomas, polypys >2 cm) or if uterine sound measurement (external os to fundus) was
<6.0 cm or >10.0 cm were excluded. Menorrhagia was verified by validated PBAC. Patients eligible for enroll- ment were required to have a history of failed medical therapy and a PBAC score ≥150.
Between November 1998 and July 2000, 107 patients were treated in a prospective study. A randomization against the Vesta electrocoagulation-balloon was started.
As the Autosuture Company stopped the Vesta project the same month, directly after the start of the study, we continued as a single-arm study: 107 premenopausal women (median age 42.2 years) with menorrhagia second- ary to DUB were enrolled. The mean PBAC score was 563 (range 194–2590). With respect to the position of the uterus, the distribution within this patient population was as follows: anteverted 52%, retroverted 22%, and mid position 26%.
OPERATIVE PROCEDURE
The uterine cavity was evaluated by means of hysteros- copy to exclude patients with submucous fibroids, polyps, and synechiae that would heavily distort the uterine cavity. The average cornu-to-cornu distance was 3.98 cm (range 2.5–5.3 cm). The anesthesia regimen was uniform for all patients, consisting of total intravenous anesthesia
(TIVA) with induction with Versed (midazolam 2.0 mg) + propofol 1% (1.5–2.5 mg/kg) + remifentanil (1 µg/kg/min).
The intraoperative anesthesia was maintained with pro- pofol 1% (5–7 mg/kg/hr) + remifentanil (0.2 µg/kg/min).
A 50/50 oxygen/air mix was delivered by using a larynx mask.
A vaginal speculum was inserted and the cervix was grasped with a tenaculum. The cavity was sounded and the measurement recorded. The length of the cervix was assessed during cerival dilatation to 7.5 mm by measuring the distance between the internal and external cervical ora. Cavity length (sound measurement − length of cer- vix) was entered into the RF controller. The NovaSure device was inserted, deployed, and properly seated in the uterine cavity. The cornu-to-cornu measurement was determined by the intrauterine measurement device and entered into the RF controller to allow a precise auto- matic calculation of power setting required for optimal treatment of a cavity of that size. The controller was activated by pressing the foot switch, and the perforation- detection cycle was followed by the ablation cycle (Figure 22.3).
At the end of the ablation cycle, the controller auto- matically terminated energy delivery and the device was closed and withdrawn from the cavity. The tenaculum and vaginal speculum were removed to conclude the pro- cedure. No prophylactic antibiotics were administered.
Treatment was measured from the start to the end of RF energy application. The average treatment time was 94 seconds (range 40–119 seconds). All adverse events and/or complications during and after the procedure were
Figure 22.3 Hysteroscopic close-up view of the right cornual area. The entire cavity appears whitish. By the special design of the device, coagulation is performed until the tubal ostium. The endometrium is vaporized, and the underlying myometrium coagulated.
procedure, 18 with clinical outcome becoming significantly better with time.
We also stratified patients by age (<40 years old,
≥40 years old) and analyzed data based on this factor (Figure 22.5). In women <40 years old, amenorrhea was achieved in 43% and hypomenorrhea in 47% (45%
spotting, 2% hypomenorrhea); in women ≥40 years old, the hypomenorrhea rate dropped to 24% (19% spotting, 5% hypomenorrhea) and amenorrhea increased to 70%.
The distribution and bleeding patterns between age groups was statistically significant using the likelihood ratio χ 2 ( L = 8.94, p = 0.0114). This difference was due primarily to distributional differences in amenorrhea rates ( L = 7.60, p = 0.005).
One patient experienced hematometra 5 months after treatment, which resulted in hysterectomy. After the fact, it was clear that hysterectomy was not the procedure of choice in her management. 8 , 21 No other hysterectomies were performed for any reason. Thus, hysterectomy or retreatment was avoided in 103 patients (97%) at 12-month follow-up.
In 2003, the 3-year follow-up data of this group were collected. As mean age at primary treatment was 42 years old, it can be assumed that nearly all patients are still premenopausal. 22
Only two patients reported climacteric symptoms whereas one women was on hormone replacement ther- apy (HRT). A successful bleeding reduction with the use of NovaSure bipolar ablation was achieved in 98% of patients at 1-year follow-up, compared with a success rate of 97.2% at 3-year follow-up (Figure 22.6). Increase in the amenorrhea rate between 6 and 36 months after abla- tion was found to be statistically significant (χ 2 p >0.004).
Because no significant difference in success rates has been observed when comparing the data for 6, 12, and 36 months, it is safe to conclude that, although becoming better with recorded. After surgery, patients were required to maintain
a menstrual diary for 12 months, even those who reported amenorrhea. In addition to a 4-week contact, follow-up visits were scheduled at 6 and 12 months. The PBAC was used to assess the amount of bleeding to correlate to the classification approved by the World Health Organization (amenorrhea, spotting, hypomenorrhea, eumenorrhea, menorrhagia). All patients were required to have FSH measured at the 12-month visit to eliminate the possibilty of false interpretation of amenorrhea.
RESULTS AT 12 AND 36 MONTHS
No intraoperative or postoperative complications or com- plications associated with anesthesia occurred. All patients were discharged in 1–4 hours. They experienced a sero- sanguineous discharge for approximately 2–4 weeks after the procedure.
No patients withdrew from the study and 106 com- pleted the 6-month follow-up. At that time, 49 women (46.2%) were amenorrheic, 45 (42.5%) were hypomen- orrheic (PBAC-1–30), and three (2.9%) were eumenor- rheic (PBAC-31–75). Nine (8.4%) were still menorrhagic (PBAC >75). Of 45 hypomenorrheic women, 36 had spotting only (PBAC-1–10).
One patient was lost to follow-up at 12 months.
Of the 105 women, 62 (58.6%) were amenorrheic, 35 (33.3%) were hypomenorrheic, and four (3.9%) were eumenorrheic. Most hypomenorrheic patients (31/35) experienced only spotting. Only four women (3.9%) were still menorrhagic (Figure 22.4).
Data comparison indicated that between 6- and 12-month follow-up the clinical results changed. There- fore, it is safe to conclude that a steady state (clinical durability plateau) is reached ≥12 months after the
0 10 20 30 40 50 60 70
6 months 12 months
Amenorrhea Spotting Hypomenorrhea Eumenorrhea Menorrhagia 49
36
9 9 3
62
31
4 4
Figure 22.4 Results at 6 and 12 months follow-up.
hysterectomy was performed in the patient who failed the ablation procedure (PBAC = 800). A third hysterectomy was performed on an amenorrheic patient, who presented with symptoms of a fast-growing myoma (preasure on the bladder) requiring surgical intervention. Therefore, at 3 years after NovaSure ablation, hysterectomy and the need for any additional surgical intervention was avoided in 97.2% and 96.3% of patients, respectively (see Figure 22.7).
LATE RESULTS
In 2005, 5-year follow-up data were collected to demon- strate the long-term follow-up results. Mean follow-up time with respect of amenorrhea, a successful steady state
is reached 6 months after the NovaSure procedure.
FAILURES
Four patients were considered failures, with PBAC scores
>75 at 12-month follow-up. One woman had a PBAC score of 800. A substantial reduction in bleeding was seen in all other patients. One woman (PBAC-250) required a second ablation, and two others were satisfied with their final bleeding status (PBAC-219 and 125) (Figure 22.7).
During the 3-year follow-up, three hysterectomies and one reablation were performed. One patient presented with hematometra at 5 months after ablation. The second
43 45
2 2 7
70
19
5 5 2
0 10 20 30 40 50 60 70
Age < 40 years old Age > 40 years old
Amenorrhea: 0 Spotting: 1–10 Hypomenorrhea: 11–30 Eumenorrhea: 31–75 Menorrhagia >75
Figure 22.5 Results at 12 months according to age.
49
36
9 9 3
62
31
4 4 4
65
26
3 3 3
75
19
3 1 2 0
10 20 30 40 50 60 70 80
6 12 3 5
Amenorrhea Spotting Hypomenorrhea Eumenorrhea Menorrhagia
Figure 22.6 Late results: steady state between 6 and 12 months; plateau phase is between 1 and 3 years; increase of amenorrhea after 5 years.
rates has been observed when comparing 6, 12, 36, and 60 months data (91.6%, 96.1%, 97%, and 98%, respec- tively) it is safe to conclude that, while becoming signifi- cantly better with time with respect of amenorrhea, a steady success state (clinical durability plateau) is reached at about 6 months after NovaSure procedure.
The hysterectomy rate of 2.9%, as well as the overall retreatment rate of 3.8%, was very low at 5-year follow-up.
Considering that no additional surgical interventions were required between 3- and 5-year follow-up, it is safe to assume that the probability of need for additional sur- gical intervention after 3 years post-NovaSure ablation is negligible.
The efficacy of an endometrial ablation device is pri- marily measured by clinical outcomes. For this ongoing follow-up evaluation, we report on 5-year amenorrhea rates, spotting rates, hypomenorrhea, and reduction to normal bleeding, as determined by PBAC. We observed a 75%
amenorrhea rate in this cohort at 5 years post procedure and an overall successful reduction of DUB was achieved in 98% of patients. Hysterectomy was avoided in 97.1%
of patients (Figure 22.8) and the need for any additional surgical intervention was less than 4%. This is quite a strik- ing improvement when compared with similar outcomes when this condition is treated with other solutions.
LATEST DEVELOPMENTS
While the classical indication for endometrial ablation is
‘dysfunctional uterine bleeding disorders’, the latest reports show the efficacy of NovaSure bipolar coagulation in the presence of polyps and myomata. Off-label use in the treatment of menometrorrhagia caused by type I and type II myomas ≤3 cm in diameter demonstrated a 95%
satisfaction rate at 12-month follow-up. 24 But indications for treatment in the presence of intracavitary diseases and late results are still missing. As the uterine cavity is more or less distorted, endometrial ablation in the presence of myomata should only be performed by very experienced surgeons to avoid complications.
As we performed all operations under general anesthe- sia (TIVA), there are first reports of bipolar endometrial ablation in an office setting under local anesthesia. Patients are prepared with a painkiller in the form of a suppository followed by a paracervical block. To avoid systemic side effects and even for a better local effect after the paracervi- cal block, an intrauterine gel is applied for pain treatment of the upper uterine part. As the operation (bipolar coag- ulation) only takes about 90 seconds, the results are satis- fying. Development of pain after NovaSure ablation is less than after other global ablation techniques. By the continous suction system, cell debris of vaporized endometrium is time at the time that this chapter was submitted was 5.8
(± 2.5 months). 23 Eight Patients reported climacteric symptoms. At this 5-year follow-up, data were available for 103 of the 107 patients enrolled in the study. Four patients were lost to follow-up between 3 and 5 years of follow-up. Of the patients lost to follow-up, two were amenorrheic, one patient was eumenorrheic, and one patient reported menorrhagia at 3-year follow-up.
At 5 years after the NovaSure procedure, 75% of patients available for follow-up reported amenorrhea (PBAC = 0). Spotting (PBAC = 1–10) was reported by 19% of patients, with an additional 3% reporting hypo- menorrhea (PBAC = 11–30). Reduction to normal bleeding (PBAC = 31–75) was reported by 1% of patients, whereas 2% continued to be menorrhagic (see Figure 22.6).
Direct comparison of the previously reported 1- and 3-year follow-up data suggests strong results stability when compared with the 5-year follow-up results (see Figure 22.6).
Statistical analyses were conducted using the McNe- mar test for the significance of change. This test was selected as an optimal and most applicable test due to its design pecifics and best applicability in comparing the patterns of responses of two nominal variables obtained from dependent samples (repeated measures in the same group). Controlling for an experiment-wise error (α = 0.05) for the three comparisons of interest (6 months vs 12 months, 12 months vs 36 months, and 36 months vs 60 months), the α per comparison was set at α = 0.015.
The results obtained suggest that improvement in amen- orrhea rate observed between 6- and 12-month follow-up (46.2% and 58.6%, respectively) was statistically signifi- cant ( p = 0.0003). A statistically significant improvement in amenorrhea was again observed between 12 and 36 months (58% and 65%, respectively) ( p = 0.0253), as well as between 36 and 60 months (65% and 75%, respectively) ( p = 0.0047). Because no significant difference in success
Failures 1. 800 →dissatisfaction →HE 2. 250 →second ablation 3. 219 →satisfied 4. 125 →satisfied
5. symptomatic myoma →HE 3 Hysterectomies =2,8%
5 months 1 year 3 years 5 years Hematometra HE
Figure 22.7 Failures (n = 107) at 36 months after NovaSure endometrial ablation. Failures: at 12 months; four patients PBAC
>75, one hematometra; at 36 months; one symptomatic myoma;
and at 60 months; no change. (Source: Center of Gynaecological Endoscopy, Hamburg, Germany.)
the NovaSure system can be successfully used and provide excellent results 19 , 20 , 23 without the need for preoperative GnRH shrinkage of the endometrium. 26 The significant risk of inadvertent energy application to the organs of the abdominal cavity as a result of an undetected uterine per- foration is always present during blind intrauterine manipulation.
NovaSure technology incorporates several imporant safety features, such as device position feedback feature and the cavity integrity assessment system (Figure 22.9).
Implementation of the cavity integrity assessment system is a revolutionary step in bringing the safety of endome- trial ablation to a new, higher level. This safety feature removed out of the uterine cavity. In this way, prostaglan-
dins synthesized in the endometrium are not set free, which would lead to contraction of uterine muscle. 25
CONCLUSION
For more than 20 years, literature data have demonstrated that endometrial ablation is an effective alternative in the treatment of excessive menstrual bleeding. Hysteroscopic ablation techniques were followed by the development of global ablation modalities. Introduction of the validated PBAC scoring system allowed for an objective compari- son of the clinical outcomes achieved with different meth- ods of endometrial ablation. Current literature data indicate that the SEATs are equal or superior to hystero- scopic ablation and deliver good clinical results, lower complication rates, and shorten operating room time, allowing for a quick recovery period.
Pretreatment with gonadotropin-releasing hormone (GnRH) agonists has proven to be advantageous in hyst- eroscopic ablation and was also found to be essential in the effectiveness of all other SEATs. NovaSure is the only endometrial ablation modality that does not require endometrial pretreatment. Published data suggest that
99.1% 99.1%
97.1% 97.1% 97.1% 97.1% 97.1% 97.1% 97.1%
98.2% 98.2%
96.2% 96.2% 96.2% 96.2% 96.2% 96.2% 96.2%
99.1%
100%
95%
96%
97%
98%
99%
100%
Ablation 6 Months 12 Months 18 Months 24 Months 30 Months 36 Months 42 Months 48 Months 54 Months 60 Months Avoidance of hysterectomy Avoidance of additional surgery
Figure 22.8 Avoidance of additional surgery and avoidance of hysterectomy.
•Predictable extension of coagulation
•Mid body
•Cornual areas
•Position control
•Cavity integrity assessment system
•Impedance control (during entire bipolar caogulation) Figure 22.9 Safety features of the NovaSure system. (Source:
Center of Gynaecological Endoscopy, Hamburg, Germany.)
Different studies have demonstrated excellent success and patient satisfaction rates achieved with NovaSure treat- ment. This method continues to be proven as a safe and very effective method of treatment for patients suffering from menorrhagia and secondary DUB. Efficacy is demonstrated by high amenorrhea and a very low retreatment rate. High amenorrhea, which appears to most accurately represent the efficacy of a system, and low-score hypomenorrhea rates are prerequisites for consistant and good long-term results.
The advantage of the very short treatment time, which in turn allows for short procedure and operating room times, low complication rates, the special safety features, and the favorable results are convincing evidence that the NovaSure system can be an attractive treatment option for patients and their physicians.
virtually eliminates the possibility of RF energy delivery in the case of an uterine wall perforation.
The geometry and size of each uterine cavity deter- mine the precise amount of power required to achieve optimal ablation depths and profile. The power level is automatically calculated based on each woman’s uterine cavity size. Regardless of power and energy requirements, the depth of endomyometrial ablation is consistent from patient to patient, as it depends on achieving adequate dessication and coagulation of endomyometrial tissues equating to an impedance of 50 Ω. In all cases, the procedure (energy delivery) self-terminates in ≤2 minutes. Specific to NovaSure is the ability to achieve a reproducible depth of ablation, independent of endo- metrial thickness.
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